Product Code: DPS FDA class 2 21 CFR 870.2340

Electrocardiograph

Cardiovascular

The Electrocardiograph is a diagnostic device used to record the electrical activity of the heart over time by placing electrodes on the skin, producing an electrocardiogram (ECG) used to detect cardiac arrhythmias, conduction abnormalities, and other cardiac conditions. It is a Class 2 device, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is DPS, regulated under 21 CFR 870.2340, within the Cardiovascular medical specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

571

FEI Numbers

184

Registration Numbers

184

Unique Applicants

291

Years Active

Basic Information

Product Code: DPS
Device Class: FDA class 2
Regulation Number: 870.2340
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 571 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243252	ZBPro Diagnostic	Jul 10, 2025	Substantially Equivalent	ZBeats Inc.
K243305	Masimo W1	Apr 03, 2025	Substantially Equivalent	Masimo Corporation
K241217	CloudHRV System (100-01-001)	Jan 16, 2025	Substantially Equivalent	Inmedix, Inc.
K241556	Cardiac Workstation (5000); Cardiac Workstation (7000)	Dec 17, 2024	Substantially Equivalent	Philips Medizin Systeme Böblingen GmbH
K240229	Masimo W1	Aug 08, 2024	Substantially Equivalent	Masimo Corporation
K232161	DeepRhythm Platform	Jun 20, 2024	Substantially Equivalent	Medicalgorithmics S.A.
K233266	MEDIBLU ECG SYSTEM	Jun 12, 2024	Substantially Equivalent	Mediblu Medical LLC
K232816	Electrocardiograph, model: ECG301	Jun 07, 2024	Substantially Equivalent	Shenzhen Le Medical Technology Co., Ltd.
K232035	Impala	Jun 07, 2024	Substantially Equivalent	AliveCor, Inc.
K232445	CSF-4 (CSF-4)	May 02, 2024	Substantially Equivalent	CardiacSense
K232823	MCG-S (AM1000)	Apr 05, 2024	Substantially Equivalent	AMCG Co., Ltd.
K231160	Cardio Q50, Cardio Q70	Dec 15, 2023	Substantially Equivalent	Bionet Co., Ltd.
K230834	CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H	Nov 21, 2023	Substantially Equivalent	Trismed Co., Ltd.
K232974	EKGenius Smart System	Nov 17, 2023	Substantially Equivalent	EKGenius LLC
K232512	Masimo W1	Nov 17, 2023	Substantially Equivalent	Masimo Corporation
K231150	Cardio P1	Nov 09, 2023	Substantially Equivalent	Bionet Co., Ltd.
K230812	Withings Scan Monitor 2.0	Aug 23, 2023	Substantially Equivalent	Withings
K223670	MESI mTablet ECG Diagnostic System, MESI mTablet ECG	Jul 28, 2023	Substantially Equivalent	MESI, Development of Medical Devices, Ltd; MESI, D.O.O.
K222902	Electrocardiograph: SE-1200 Pro and SE-1201 Pro	Jul 28, 2023	Substantially Equivalent	Edan Instruments, Inc.
K223013	AccurECG Analysis System	Jun 23, 2023	Substantially Equivalent	AccurKardia, Inc.
K221260	CSF-3	Jan 06, 2023	Substantially Equivalent	CardiacSense
K221141	PageWriter TC35 Cardiograph	Dec 02, 2022	Substantially Equivalent	Medizin Systeme Boblingen GmbH
K220535	Cardio10	Nov 15, 2022	Substantially Equivalent	Bionet Co., Ltd.
K221321	MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System	Oct 18, 2022	Substantially Equivalent	GE Medical Systems Information Technologies, Inc.
K212163	Coala Heart Monitor	Apr 14, 2022	Substantially Equivalent	Coala Life AB
K212278	Electrocardiograph	Apr 07, 2022	Substantially Equivalent	Edan Instruments, Inc.
K220362	LE-12CH	Mar 25, 2022	Substantially Equivalent	CAF Medical Solutions Inc.
K212112	Cardiologs Holter Platform	Nov 18, 2021	Substantially Equivalent	Cardiologs Technologies
K201456	Scan Monitor	Oct 05, 2021	Substantially Equivalent	Withings SA
K210140	electrocardiograph: SE-1202	Oct 01, 2021	Substantially Equivalent	Edan Instruments, Inc
K210560	Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph	Jun 30, 2021	Substantially Equivalent	Philips Medical Systems
K203786	MAC 7 - Resting ECG Analysis System	Apr 30, 2021	Substantially Equivalent	GE Medical Systems Information Technologies, Inc.
K200884	B-Secur HeartKey Software Library	Dec 07, 2020	Substantially Equivalent	B-Secur Ltd.
K191738	PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph	Sep 29, 2020	Substantially Equivalent	Philips Medical Systems
K193415	physIQ Heart Rhythm and Respiration Module	Jun 11, 2020	Substantially Equivalent	physIQ, Inc
K200036	AI-ECG Tracker	Mar 20, 2020	Substantially Equivalent	Shenzhen Carewell Electronics Co., Ltd.
K183425	CARDIOVIT AT-102 G2	Mar 02, 2020	Substantially Equivalent	Schiller AG
K191692	KardioScreen	Jan 10, 2020	Substantially Equivalent	iMedrix Inc. (formerly Piitech Inc.)
K183322	physIQ Heart Rhythm and Respiratory Module	Jul 10, 2019	Substantially Equivalent	physIQ, Inc
K182571	CardioFlux with Faraday Analytical Cloud	Mar 15, 2019	Substantially Equivalent	Genetesis Inc.
K182093	ZOLL ECG Analysis Software	Jan 28, 2019	Substantially Equivalent	ZOLL Manufacturing Corporation
K183369	COR12 ECG	Dec 28, 2018	Substantially Equivalent	Corscience GmbH & Co.
K182790	Cardio-TriTest v6.5	Dec 14, 2018	Substantially Equivalent	Cardio-Phoenix Inc.
K181998	CardioBand ECG Event Recorder	Nov 15, 2018	Substantially Equivalent	Samsung Strategy and Innovation Center (SSIC)
K173830	MAC VU360 Resting ECG Analysis System	Sep 18, 2018	Substantially Equivalent	GE Medical Systems Information Technologies, Inc.
K173952	Universal SmartECG	Aug 28, 2018	Substantially Equivalent	VectraCor, Inc.
K180234	physiQ Heart Rhythm Module	Aug 10, 2018	Substantially Equivalent	physiQ Inc.
K172778	CheckMyHeart Plus	Jul 05, 2018	Substantially Equivalent	DailyCare Biomedical, Inc
K172068	Kenz Cardico1211	Jun 01, 2018	Substantially Equivalent	Suzuken Co.,Ltd.
K173226	CardiMax Electrocardiograph	Apr 16, 2018	Substantially Equivalent	Fukuda Denshi USA, Inc.
K180242	HeRO Symphony, HeRO ES, HeRO solo/duet	Feb 28, 2018	Substantially Equivalent	Medical Predictive Science Corporation
K162665	MiCor A100 Wearable ECG Recorder	Jan 26, 2018	Substantially Equivalent	MITAC INTERNATIONAL CORP.
K171942	Electrocardiograph	Jan 24, 2018	Substantially Equivalent	Edan Instruments, Inc.
K171360	CONTEC Electrocardiograph	Jan 22, 2018	Substantially Equivalent	Contec Medical Systems Co., LTD.
K171517	Digital Electrocardiograph	Jan 11, 2018	Substantially Equivalent	Biocare Bio-Medical Equipment Co., Ltd.
K163607	ECG Acquisition Systems	Dec 15, 2017	Substantially Equivalent	VALES & HILLS BIOMEDICAL TECH. LTD.
K170154	Creavo Vitalscan Magnetocardiograph	Oct 12, 2017	Substantially Equivalent	Creavo Medical Technologies, Ltd.
K171943	Electrocardiograph	Sep 25, 2017	Substantially Equivalent	Edan Instruments, Inc.
K170182	CARDIOVIT FT-1	Jul 19, 2017	Substantially Equivalent	SCHILLER AG
K170568	CardioLogs ECG Analysis Platform	Jun 26, 2017	Substantially Equivalent	Cardiologs Technologies
K170995	Electrocardiograph	Jun 02, 2017	Substantially Equivalent	Edan Instruments, Inc.
K170954	Portable ECG Monitor	May 30, 2017	Substantially Equivalent	CONTEC Medical Systems Co.,Ltd
K160667	Anybattery C2 Rechargeable Battery	May 11, 2017	Substantially Equivalent	Anybattery, Inc.
K160876	PC ECG	Feb 15, 2017	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K160746	CARDIOLINE touchECG	Nov 02, 2016	Substantially Equivalent	CARDIOLINE S.p.A
K160840	ECG100+, ECG200+	Aug 12, 2016	Substantially Equivalent	CARDIOLINE S.p.A
K152135	Quantitative Electrocardiographic Detector (QED 2000)	Aug 09, 2016	Substantially Equivalent	ACME Portable Machines, Inc.
K161302	PC ECG	Jul 01, 2016	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K152863	Portable ECG Monitor	Jun 22, 2016	Substantially Equivalent	CONTEC MEDICAL SYSTEMS CO., LTD
K152043	Diagnostic Station DS20	May 06, 2016	Substantially Equivalent	SCHILLER AG
K151135	MODEL 621/624 BIOMAGNETOMETER	Mar 15, 2016	Substantially Equivalent	TRISTAN TECHNOLOGIES, INC
K142969	ANI Monitor	Feb 23, 2016	Substantially Equivalent	MDOLORIS MEDICAL SYSTEMS SAS
K160092	Digital Electrocardiograph	Feb 12, 2016	Substantially Equivalent	SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
K152427	PC ECG	Feb 05, 2016	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K152944	Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems	Jan 06, 2016	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K152384	Digital Electrocardiograph	Dec 18, 2015	Substantially Equivalent	SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
K150564	Spaulding Electrocardiograph 2100iQ	Aug 12, 2015	Substantially Equivalent	Spaulding Clinical Research, LLC
K143432	Cardio-TriTest	Jun 03, 2015	Substantially Equivalent	CARDIO-PHOENIX INC.
K143436	InvisionECG System	May 21, 2015	Substantially Equivalent	InvisionHeart Inc.
K142551	QANS (Quantitative Autonomic Nervous System) Monitoring System	Apr 16, 2015	Substantially Equivalent	HHSsystems, LLC
K142693	ZywieAI Software Library	Feb 20, 2015	Substantially Equivalent	Zywie, Inc.
K141946	DIGITAL ELECTROCARDIOGRAPH	Feb 13, 2015	Substantially Equivalent	SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
K133985	DIGITAL ELECTROCARDIOGRAPH	Jan 22, 2015	Substantially Equivalent	SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
K142288	MAC 800 Resting ECG Analysis System	Dec 03, 2014	Substantially Equivalent	GE MEDICAL SYSTEMS CHINA CO., LTD.
K140020	HYPERQ ACS-100 SYSTEM	Oct 28, 2014	Substantially Equivalent	BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD.
K142105	ELI 380 ELECTROCARDIOGRAPH	Sep 05, 2014	Substantially Equivalent	MORTARA INSTRUMENT, INC
K141582	CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION	Jul 11, 2014	Substantially Equivalent	WELCH ALLYN
K131858	DIGITAL ELECTROCARDIOGRAPH	Jun 11, 2014	Substantially Equivalent	GUANGDONG BIOLIGHT MEDITECH CO., LTD.
K131900	CONTEC ELECTROCARDIOGRAPH	Mar 05, 2014	Substantially Equivalent	CONTEC MEDICAL SYSTEM CO., LTD.
K131503	SE-601 SERIES ELECTROCARDIOGRAPH	Feb 25, 2014	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K122632	GUAVA II	Feb 11, 2014	Substantially Equivalent	CARDIOCOMM SOLUTIONS, INC.
K130921	ALIVECOR HEART MONITOR OTC	Feb 06, 2014	Substantially Equivalent	ALIVECOR, INC.
K132758	DIGITAL ELECTROCARDIOGRAPH	Jan 30, 2014	Substantially Equivalent	SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD.
K133622	MAC 2000 ECG ANALYSIS SYSTEM	Jan 23, 2014	Substantially Equivalent	WIPRO GE HEALTHCARE
K131819	PC ECG	Nov 22, 2013	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K131262	DIGITAL ELECTROCARDIOGRAPHS	Nov 14, 2013	Substantially Equivalent	SONOSCAPE COMPANY LIMITED
K132068	PHILIPS DXL 12/16-LEAD ECG ALGORITHM	Sep 26, 2013	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K130409	ALIVECOR HEART MONITOR	Sep 06, 2013	Substantially Equivalent	ALIVECOR, INC.
K130207	SPACELABS HEALTHCARE CARDIOEXPRESS	Jul 23, 2013	Substantially Equivalent	SPACELABS HEALTHCARE LTD.
K131572	MICRO AMBULATORY ECG RECORDER	Jul 22, 2013	Substantially Equivalent	DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD
K131573	CP150 ELECTROCARDIOGRAPH	Jul 03, 2013	Substantially Equivalent	WELCH ALLYN, INC.
K121825	CS-MAG II	Mar 11, 2013	Substantially Equivalent	BIOMAGNETIK-PARK GMBH
K123816	DIGITAL ELECTROCARDIOGRAPHS	Feb 27, 2013	Substantially Equivalent	SHENZHEN BIOCARE ELECTRONICS CO., LTD
K123217	CARDEASCREEN	Feb 05, 2013	Substantially Equivalent	CARDEA ASSOCIATES INC
K120770	QT GUARD PLUS ANALYSIS SYSTEM	Dec 06, 2012	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K122356	ALIVECOR HEART MONITOR FOR IPHONE	Nov 19, 2012	Substantially Equivalent	ALIVECOR, INC.
K122712	DIGITAL ELECTROCARDIOGRAPH	Oct 25, 2012	Substantially Equivalent	SHENZHEN BIOCARE ELECTRONICS CO., LTD
K122073	ELI 280 ELECTROCARDIOGRAPH	Aug 02, 2012	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K120865	RSCRIBE ELECTROCARDIOGRAPH	Jul 19, 2012	Substantially Equivalent	MORTARA INSTRUMENT, INC
K112622	HANDHELD ECG MONITOR	Jul 19, 2012	Substantially Equivalent	BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
K113306	CARDIO 7	Jul 16, 2012	Substantially Equivalent	BIONET CO., LTD.
K121009	HEARTCHECK ECG PEN WITH GEMS HOME	May 17, 2012	Substantially Equivalent	CARDIO COMM SOLUTIONS, INC.
K113485	ELECTROCARDIOGRAPH	Apr 25, 2012	Substantially Equivalent	SHENZHEN CAREWELL ELECTRONICS CO., LTD
K113144	PAGEWRITER TC 20, 30, 50, 70	Apr 03, 2012	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K120188	ELECTROCARDIOGRAPH	Mar 16, 2012	Substantially Equivalent	EDAN INSTRUMENTS INC
K112959	CALG-STR EXERCISE ECG ANALYSIS ALGORITHM	Jan 26, 2012	Substantially Equivalent	PHILIPS HEALTHCARE
K111159	HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME	Dec 22, 2011	Substantially Equivalent	CARDIO COMM SOLUTIONS, INC.
K113234	MOBCARDIO SYSTEM	Nov 17, 2011	Substantially Equivalent	MOBHEALTH INCORPORATION
K102378	VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI	Nov 02, 2011	Substantially Equivalent	VECTRACOR, INC
K103791	PHYSIOGLOVE ES WITH ECG ANALYSIS	Oct 21, 2011	Substantially Equivalent	COMMWELL LTD.
K112431	DIGITAL ELECTROCARDIOGRAPH	Sep 22, 2011	Substantially Equivalent	SHENZHEN BIOCARE ELECTRONICS CO., LTD
K111438	REKA E100	Sep 12, 2011	Substantially Equivalent	REKA PTE LTD
K111805	ECG SERIES ELECTROCARDIOGRAPH	Aug 24, 2011	Substantially Equivalent	ADVANCED INSTRUMENTATIONS, INC.
K112135	ECG-6 SERIES ELECTROCARDIOGRAPH	Aug 05, 2011	Substantially Equivalent	ADVANCED INSTRUMENTATIONS, INC.
K110328	ACG-8511 PORTABLE ECG MONITOR	Jul 15, 2011	Substantially Equivalent	ANDON HEALTH CO.,LTD
K103077	ECG PEN	Jul 13, 2011	Substantially Equivalent	MERIDIAN DYNAMICS BIOMEDICAL, INC
K111601	HERO	Jul 08, 2011	Substantially Equivalent	MEDICAL PREDICTIVE SCIENCE CORP.
K102767	CARDIO XP	Jun 03, 2011	Substantially Equivalent	BIONET CO., LTD.
K103765	MAC 600 RESTING ECG ANALYSIS SYSTEM	May 17, 2011	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
K110266	MAC 5500 HD, MAC 3500	Apr 29, 2011	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
K101867	VICOR PD2I ANALYZER	Apr 14, 2011	Substantially Equivalent	VICOR TECHNOLOGIES, INC.
K103427	MOBILEECG SYSTEM	Mar 24, 2011	Substantially Equivalent	MEMTEC CORP.
K103640	MIDMARK IQECG	Mar 22, 2011	Substantially Equivalent	BRENTWOOD MEDICAL TECHNOLOGY CORP.
K110065	SPAULDING IQ ELECTROCARDIOGRAPH	Mar 02, 2011	Substantially Equivalent	SPAULDING CLINICAL RESEARCH, LLC
K101876	DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010	Mar 01, 2011	Substantially Equivalent	SHENZHEN BIOCARE ELECTRONICS CO., LTD
K101569	V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER	Mar 01, 2011	Substantially Equivalent	TaiDoc Technology Corporation
K102206	ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10	Feb 18, 2011	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K101016	ANS SYSTEM	Jan 28, 2011	Substantially Equivalent	CAIRD TECHNOLOGY
K102854	PC ECG	Dec 03, 2010	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K102830	ELECTROCARDIOGRAPH	Dec 02, 2010	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K100813	QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB	Jul 23, 2010	Substantially Equivalent	PULSE BIOMEDICAL, INC.
K101403	ELI 250 ELECTROCARDIOGRAPH	Jul 02, 2010	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K101115	ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150	Jun 18, 2010	Substantially Equivalent	MORTARA INSTRUMENT, INC
K093211	CARECENTER MD	Jun 03, 2010	Substantially Equivalent	CARDIAC SCIENCE CORPORATION
K100127	ELI 230 ELECTROCARDIOGRAPH	Apr 16, 2010	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K093869	SE-601 SERIES ELECTROCARDIOGRAPH	Apr 01, 2010	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K093872	HANDHELD ECG MONITOR, MODEL MD100	Mar 31, 2010	Substantially Equivalent	BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
K093339	ELI PC ELECTROCARDIOGRAPH	Feb 19, 2010	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K093172	QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)	Jan 20, 2010	Substantially Equivalent	DYNACARDIA, INC.
K092663	ELI 350 ELECTROCARDIOGRAPH	Dec 14, 2009	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K092010	PC ECG, MODEL SE-1010	Oct 22, 2009	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K083715	BELTBEAT WF-400	Sep 15, 2009	Substantially Equivalent	BONUS COMMUNICACIONES SRL
K092576	GEM HEART ONE/ONE+	Sep 04, 2009	Substantially Equivalent	GEM-MED S.L.
K090936	SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A	Aug 25, 2009	Substantially Equivalent	CONTEC MEDICAL SYSTEM CO., LTD.
K091513	SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200	Jul 24, 2009	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K091397	ECSCOPE 200	Jul 08, 2009	Substantially Equivalent	DYANSYS, INC.
K090367	SE-601 SERIES ELECTROCARDIOGRAPH	Jun 03, 2009	Substantially Equivalent	EDAN INSTRUMENTS, INC.
K091358	ECSCOPE 100	May 28, 2009	Substantially Equivalent	DYANSYS, INC.
K090249	MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM	Apr 03, 2009	Substantially Equivalent	HARBINGER MEDICAL, INC.
K082967	MORTARA STRESS ECHO BED	Mar 26, 2009	Substantially Equivalent	MEDICAL POSITIONING, INC.
K090483	SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS	Mar 20, 2009	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K090212	MAC 800 RESTING ECG ANALYSIS SYSTEM	Feb 19, 2009	Substantially Equivalent	GE MEDICAL SYST. INFORMATION TECHNOLOGIES
K082124	CARDITTE MICROTEL	Feb 19, 2009	Substantially Equivalent	ET MEDICAL DEVICES SPA
K082946	MORTARA ELI 350 ELECTROCARDIOGRAPH	Dec 29, 2008	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K082709	VICOR PD2I ANALYZER, VERSION 2.1	Dec 29, 2008	Substantially Equivalent	VICOR TECHNOLOGIES, INC.
K082380	VICARDIO 12B	Dec 03, 2008	Substantially Equivalent	ENERGY-LAB TECHNOLOGIES GMBH
K082013	CLUE MEDICAL AND CLUE MEDICAL BASIC	Nov 10, 2008	Substantially Equivalent	TELOVITAL GMBH TELEMEDIZIN
K080933	HANDHELD ECG MONITOR, MODEL MD100	Sep 26, 2008	Substantially Equivalent	BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
K082312	PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)	Sep 12, 2008	Substantially Equivalent	HEARTSCAPE TECHNOLOGIES LTD
K082173	Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S	Aug 26, 2008	Substantially Equivalent	CARDIAC SCIENCE CORPORATION
K081437	MAC 1600 ECG ANALYSIS SYSTEM	Jul 15, 2008	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K081473	HERO, VERSION 2.0	Jun 27, 2008	Substantially Equivalent	MEDICAL PREDICTIVE SCIENCE CORP.
K080999	PAGEWRITER CARDIOGRAPH	May 09, 2008	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K080884	QHRV 1 - HEALTH ASSESSMENT SYSTEM	Apr 11, 2008	Substantially Equivalent	MEDTECHS, LLC
K073625	MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM	Jan 25, 2008	Substantially Equivalent	GE HEALTHCARE SYSTEMS INFORMATION TECHNOLOGIES
K080036	PORTABLE ECSCOPE 12I	Jan 16, 2008	Substantially Equivalent	DYANSYS, INC.
K072449	CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS	Nov 29, 2007	Substantially Equivalent	WELCH ALLYN, INC.
K071168	THE PORTABLE ANSISCOPE	Aug 31, 2007	Substantially Equivalent	DYANSYS, INC.
K072353	PORTABLE ECSCOPE	Aug 30, 2007	Substantially Equivalent	DYANSYS CORP
K072217	ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M	Aug 30, 2007	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K072060	QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V	Aug 17, 2007	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K061123	PALM ECG RECORDER, MODEL EP-201/202	Jun 29, 2007	Substantially Equivalent	PARAMA-TECH COMPANY., LTD
K070614	CORSCREEN	May 04, 2007	Substantially Equivalent	VIASYS HEALTHCARE GMBH
K070136	AUDICOR 200 SYSTEM, MODELS 200D AND 200S	Apr 13, 2007	Substantially Equivalent	INOVISE MEDICAL, INC.
K062282	MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0	Mar 22, 2007	Substantially Equivalent	MONEBO TECHNOLOGIES, INC.
K070539	MORTARA ELI 10 ELECTROCARDIOGRAPH	Mar 15, 2007	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K062894	INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0	Feb 08, 2007	Substantially Equivalent	DAILYCARE BIOMEDICAL INC
K062677	ELI 350 ELECTROCARDIOGRAPH	Nov 15, 2006	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K062469	VOYAGER 12	Nov 03, 2006	Substantially Equivalent	DEL MAR REYNOLDS MEDICAL, LTD.
K062068	INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0	Oct 27, 2006	Substantially Equivalent	INTELWAVE, LLC
K060766	PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801	Jun 09, 2006	Substantially Equivalent	OMRON HEALTHCARE, INC.
K052511	CARDIOFAX CE, MODEL ECG-1500 A	May 24, 2006	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K050674	PHYSIOGLOVE ES	Apr 25, 2006	Substantially Equivalent	COMMWELL LTD.
K060167	ATRIA 3100, ATRIA 6100	Apr 19, 2006	Substantially Equivalent	CARDIAC SCIENCE CORPORATION
K052898	IQMARK EZ STRESS	Mar 28, 2006	Substantially Equivalent	BRENTWOOD MEDICAL TECHNOLOGY CORP.
K051163	GALIX ECG PROFESSIONAL STATION	Jan 31, 2006	Substantially Equivalent	GALIX BIOMEDICAL INSTRUMENTATION, INC.
K052295	CARDIOSOFT PC ECG, USB VERSION	Jan 13, 2006	Substantially Equivalent	CARDIOSOFT, L.P.
K052303	READMYHEART, MODEL RMH2.0	Dec 16, 2005	Substantially Equivalent	DAILYCARE BIOMEDICAL INC
K053083	DATRIX CARDIO WIFI ELECTROCARDIOGRAPH	Nov 30, 2005	Substantially Equivalent	DATRIX
K051534	CARDIOLINE AR 600, AR 1200, AR 2100	Oct 05, 2005	Substantially Equivalent	ET MEDICAL DEVICES SPA
K052049	PHILIPS 12-LEAD ALGORITHM	Aug 26, 2005	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K050620	READMYHEART, MODEL RMH3.0	Jul 14, 2005	Substantially Equivalent	DAILYCARE BIOMEDICAL INC
K050858	ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM	Jun 29, 2005	Substantially Equivalent	HEARTLAB, INC.
K051126	CARDIOSCOPE SONOPLUS 3000	May 19, 2005	Substantially Equivalent	PULSONIC AG, MEDICAL TECHNOLOGY
K050686	CARDIOVIT AT-10PLUS	May 04, 2005	Substantially Equivalent	SCHILLER AG
K043380	MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1	Apr 26, 2005	Substantially Equivalent	MONEBO TECHNOLOGIES, INC.
K050074	12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200	Mar 22, 2005	Substantially Equivalent	WELCH ALLYN, INC.
K043074	LIBERTY SYSTEM	Feb 22, 2005	Substantially Equivalent	INOVISE MEDICAL, INC.
K042827	CARDIOFAX CE, MODEL PEA-1110K	Jan 06, 2005	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K042814	READMYHEART	Jan 06, 2005	Substantially Equivalent	DAILYCARE BIOMEDICAL INC
K042177	MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM	Aug 27, 2004	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033488	CMI MAGNETOCARDIOGRAPH	Jul 07, 2004	Substantially Equivalent	CMI CARDIOMAG IMAGING INC
K031557	CARDIOVIT AT-102	Apr 14, 2004	Substantially Equivalent	SCHILLER AG
K040313	HRV TOOLS	Apr 06, 2004	Substantially Equivalent	DEL MAR REYNOLDS MEDICAL, LTD.
K032145	AUDICOR UPGRADE SYSTEM	Oct 31, 2003	Substantially Equivalent	INOVISE MEDICAL, INC.
K032200	ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH	Oct 03, 2003	Substantially Equivalent	REMCO ITALIA S.P.A.
K024283	CARDIODIRECT, MODELS 12M, 12I, 12S	Aug 01, 2003	Substantially Equivalent	REYNOLDS MEDICAL LTD.
K031182	ELI 200+ AUDICOR	Jul 25, 2003	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K031422	PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291	Jul 03, 2003	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K030535	EKGCARD SYSTEM	Jun 11, 2003	Substantially Equivalent	QRS DIAGNOSTIC, LLC.
K030104	PRIME ECG SYSTEM	Jun 11, 2003	Substantially Equivalent	MERIDIAN MEDICAL TECHNOLOGIES, INC.
K024278	PACEART SYSTEM	May 29, 2003	Substantially Equivalent	MEDTRONIC VASCULAR
K021230	HERO	May 09, 2003	Substantially Equivalent	MEDICAL DECISION NETWORKS
K022618	X-SCRIBE II	Sep 06, 2002	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K022152	HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS	Jul 16, 2002	Substantially Equivalent	CAMBRIDGE HEART, INC.
K022149	CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000	Jul 16, 2002	Substantially Equivalent	CAMBRIDGE HEART, INC.
K013615	MICRO-INDUCTION 1000 SYSTEM	May 29, 2002	Substantially Equivalent	HARBINGER MEDICAL, INC.
K021171	Q-STRESS ECHO BED	May 08, 2002	Substantially Equivalent	MEDICAL POSITIONING, INC.
K020366	GLOBAL ECG MANAGEMENT SYSTEM (GEMS)	Apr 30, 2002	Substantially Equivalent	CARDIOCOMM SOLUTIONS, INC.
K020708	PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES	Apr 25, 2002	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K014262	COSMED QUARK C12/QUARK T12	Mar 26, 2002	Substantially Equivalent	COSMED S.R.L.
K012414	PRIME ECG SYSTEM	Mar 06, 2002	Substantially Equivalent	MERIDIAN MEDICAL TECHNOLOGIES, INC.
K013717	BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY	Feb 06, 2002	Substantially Equivalent	BRENTWOOD MEDICAL TECHNOLOGY CORP.
K013367	CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH	Dec 13, 2001	Substantially Equivalent	REYNOLDS MEDICAL LTD.
K012686	CAIRD TECHNOLOGY HOLTER 2000	Dec 13, 2001	Substantially Equivalent	CAIRD TECHNOLOGY
K013565	CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000	Nov 21, 2001	Substantially Equivalent	CAMBRIDGE HEART, INC.
K013564	MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS	Nov 21, 2001	Substantially Equivalent	CAMBRIDGE HEART, INC.
K012264	MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC	Oct 10, 2001	Substantially Equivalent	NATIONAL CUSTOM ENT., INC.
K012263	MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024	Oct 10, 2001	Substantially Equivalent	NATIONAL CUSTOM ENT., INC.
K012540	BLY-501 ADAPTOR	Sep 26, 2001	Substantially Equivalent	MICROMEDICAL INDUSTRIES, LTD.
K011436	MOBILE-PATIENT VIEWER	Jul 05, 2001	Substantially Equivalent	DATA CRITICAL CORPORATION
K011177	BCI ADVISOR VITAL SIGNS MONITOR (9200)	May 23, 2001	Substantially Equivalent	BCI, INC.
K010955	BMT ANSCORE HEALTH MANAGEMENT SYSTEM	Apr 26, 2001	Substantially Equivalent	BOSTON MEDICAL TECHNOLOGIES, INC.
K010822	AB CARDIETTE START 200 HV	Apr 18, 2001	Substantially Equivalent	H&C MEDICAL DEVICES SPA
K010758	HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS	Apr 12, 2001	Substantially Equivalent	CAMBRIDGE HEART, INC.
K010505	TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY	Mar 09, 2001	Substantially Equivalent	BRENTWOOD MEDICAL TECHNOLOGY CORP.
K002822	VERTEX SYSTEM	Jan 31, 2001	Substantially Equivalent	MEDICAL POSITIONING, INC.
K003392	CARDIO MONITOR CENTER VISION; MODEL S-CV7-00	Jan 25, 2001	Substantially Equivalent	SHL TELEMEDICINE INTERNATIONAL LTD.
K001896	KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC	Jan 08, 2001	Substantially Equivalent	SUZUKEN CO., LTD.
K002197	CARTOUCH	Dec 27, 2000	Substantially Equivalent	CARDIONICS, INC.
K002473	WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES	Nov 08, 2000	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K002459	PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH	Nov 08, 2000	Substantially Equivalent	AGILENT TECHNOLOGIES, INC.
K002074	AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES	Oct 04, 2000	Substantially Equivalent	H&C MEDICAL DEVICES SPA
K993875	BMT ANSCORE HEALTH MANAGEMENT SYSTEM	Aug 11, 2000	Substantially Equivalent	BOSTON MEDICAL TECHNOLOGIES, INC.
K001492	QUINTON Q-STRESS, MODEL 000483	Aug 09, 2000	Substantially Equivalent	QUINTON, INC.
K001034	MODEL APS ALTERNANS PROCESSING SYSTEM	Jun 09, 2000	Substantially Equivalent	CAMBRIDGE HEART, INC.
K000645	GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11	May 24, 2000	Substantially Equivalent	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K993414	PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2	Apr 07, 2000	Substantially Equivalent	PRUCKA ENGINEERING, INC.
K991786	MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION	Nov 18, 1999	Substantially Equivalent	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K991831	BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1	Jun 11, 1999	Substantially Equivalent	BOSTON MEDICAL TECHNOLOGIES, INC.
K972991	MONITOR ONE NDX	Dec 03, 1998	Substantially Equivalent	QMED, INC.
K981697	CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM	Oct 14, 1998	Substantially Equivalent	CAMBRIDGE HEART, INC.
K974220	MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE	Aug 25, 1998	Substantially Equivalent	MICROMEDICAL, INC.
K981807	CARDIOVISION SOFTWARE, MODEL S-CV5-96	Aug 19, 1998	Substantially Equivalent	SHL TELEMEDICINE INTERNATIONAL LTD.
K973426	ANS 2000 ECG MONITOR AND RESPIRATION PACER	Aug 12, 1998	Substantially Equivalent	D. E. HOKANSON, INC.
K961798	CT 200 ELECTROCARDIOGRAPH	Aug 05, 1998	Substantially Equivalent	MACQUARIE MEDICAL SYSTEMS
K981951	CT 100 ELECTROCARDIOGRAPH	Jul 28, 1998	Substantially Equivalent	MACQUARIE MEDICAL SYSTEMS
K980362	MRI COMPATIBLE MONITOR AND ACCESSORIES	Jun 30, 1998	Substantially Equivalent	DATEX-ENGSTROM, INC.
K972996	EASY ECG PC BASED ELECTROCARDIOGRAPH	Apr 28, 1998	Substantially Equivalent	ATES MEDICAL S.R.L.
K974351	BIOLOG 3000 ELECTROCARDIOGRAPH	Apr 01, 1998	Substantially Equivalent	MICROMEDICAL, INC.
K974746	M1765A ECG MANAGER	Mar 18, 1998	Substantially Equivalent	HEWLETT-PACKARD CO.
K972603	ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B	Mar 11, 1998	Substantially Equivalent	DR. LEE CO., LTD.
K974079	FORMULA FOR ARCHIMED	Jan 22, 1998	Substantially Equivalent	BIOSOUND ESAOTE, INC.
K973437	HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES	Dec 03, 1997	Substantially Equivalent	HEWLETT-PACKARD GMBH
K972746	ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100	Oct 21, 1997	Substantially Equivalent	ALEXANDER MFG. CO.
K972199	SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS	Sep 25, 1997	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K971038	KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE	Sep 24, 1997	Substantially Equivalent	KONTRON INSTRUMENTS LTD.
K972310	NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH	Aug 20, 1997	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K964784	SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)	Aug 13, 1997	Substantially Equivalent	QUINTON, INC.
K964408	POSEIDON CARDIAC MONITORING SYSTEM (PCMS)	Jul 23, 1997	Substantially Equivalent	INSTROMEDIX, INC.
K963578	PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)	Jun 30, 1997	Substantially Equivalent	INTL. PRODUCTS, INC.
K970787	ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)	May 14, 1997	Substantially Equivalent	ALEXANDER MFG. CO.
K963198	PS-41 6M PATIENT SIMULATOR	Mar 05, 1997	Substantially Equivalent	METRON U.S., INC.
K963400	NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER	Nov 26, 1996	Substantially Equivalent	NELLCOR PURITAN BENNETT, INC.
K961247	AS/3 LIGHT MONITOR	Oct 23, 1996	Substantially Equivalent	DATEX DIVISION INSTRUMENTARIUM CORP.
K961401	HP CATHSTATION - MODEL M1264B	Oct 08, 1996	Substantially Equivalent	HEWLETT-PACKARD CO.
K955891	CARDIOVIEW TRANSTELEPHONIC SOFTWARE	Oct 08, 1996	Substantially Equivalent	MICROMEDICAL, INC.
K951128	MEDILOG STRESSLINK	Aug 28, 1996	Substantially Equivalent	OXFORD MEDICAL, INC.
K960321	CARDIOCATH CATHETERIZATION LAB SYSTEM	Aug 21, 1996	Substantially Equivalent	PRUCKA ENGINEERING, INC.
K955546	PATIENT MONITOR MODEL 405P	Aug 16, 1996	Substantially Equivalent	IVY BIOMEDICAL SYSTEMS, INC.
K955113	DINAMAP SELECT MULTI-PARAMETER SYSTEM	Aug 15, 1996	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.
K955416	CARDIMAX MODEL FX-2111	Jul 15, 1996	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K955045	OMNI-TRAK PATIENT MONITORING SYSTEM	Jul 11, 1996	Substantially Equivalent	INVIVO RESEARCH, INC.
K955642	NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER	Jul 02, 1996	Substantially Equivalent	NELLCOR PURITAN BENNETT, INC.
K960449	PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)	May 30, 1996	Substantially Equivalent	BIOSENSOR CORP.
K950989	CARDIOSMART	May 13, 1996	Substantially Equivalent	HELLIGE GMBH
K950018	CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM	Feb 29, 1996	Substantially Equivalent	CAMBRIDGE HEART, INC.
K954066	MINISCOPE MS-3	Oct 27, 1995	Substantially Equivalent	SCHILLER AMERICA, INC.
K950004	HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER	Oct 24, 1995	Substantially Equivalent	AEROTEL, LTD.
K953415	6200 VITAL SIGNS MONITOR	Oct 19, 1995	Substantially Equivalent	BCI INTL., INC.
K952173	HEWLETT-PACKARD MODEL M1264B CATHSTATION	Aug 11, 1995	Substantially Equivalent	HEWLETT-PACKARD CO.
K945626	QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH	Jun 28, 1995	Substantially Equivalent	QUINTON, INC.
K943709	DINAMAP PLUS VITAL SIGNS MONOITOR	Jun 16, 1995	Substantially Equivalent	CRITIKON COMPANY,LLC
K950779	HEART RATE VARIABILITY SOFTWARE OPTION	Apr 25, 1995	Substantially Equivalent	SPACELABS, INC.
K946205	CARDIOVIT AT-1, P-80	Mar 16, 1995	Substantially Equivalent	SCHILLER AMERICA, INC.
K933156	DATEX AS/3 PATIENT MONITOR	Dec 30, 1994	Substantially Equivalent	DATEX DIVISION INSTRUMENTARIUM CORP.
K935394	MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION	Oct 20, 1994	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K942629	NCE REPLACEMENT BATTERIES	Aug 18, 1994	Substantially Equivalent	NATIONAL CUSTOM ENT., INC.
K941811	HP M1175A, M1176A, COMPONENT MONITORING SYSTEM	May 17, 1994	Substantially Equivalent	HEWLETT-PACKARD CO.
K934439	RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR	Feb 17, 1994	Substantially Equivalent	PORTABLE POWER SYSTEMS, INC.
K933065	BATTERY PACK# S1009LA	Feb 17, 1994	Substantially Equivalent	PORTABLE POWER SYSTEMS, INC.
K933404	CRITIKON CENTRAL STATIN MONITOR	Feb 09, 1994	Substantially Equivalent	CRITIKON COMPANY,LLC
K923406	BIOSCOPE	Sep 22, 1993	Substantially Equivalent	BIOTRONIK, GMBH & CO.
K924544	CARDIAX	Jul 29, 1993	Substantially Equivalent	FAIRLAKE MARKETING GROUP, INC.
K921930	SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI	May 07, 1993	Substantially Equivalent	SIEMENS MEDICAL ELECTRONICS
K930558	MORTARA INSTRUMENT, INC. E-SCRIBE	Apr 27, 1993	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K922703	THE ACTA FORMULA	Apr 27, 1993	Substantially Equivalent	BIOSOUND, INC.
K930134	9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT	Apr 09, 1993	Substantially Equivalent	S & W MEDICO TEKNIK
K923221	KING OF HEARTS SCEPTER	Mar 08, 1993	Substantially Equivalent	INSTROMEDIX, INC.
K922927	MORTARA INSTRUMENT ST CENTRAL STATION	Nov 10, 1992	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K922291	PERSONAL 120/210 LAPTOP STRESS OPTION	Nov 04, 1992	Substantially Equivalent	BIOSOUND, INC.
K920020	CARDIO-CARD ECG MANAGEMENT SYSTEM	Jul 09, 1992	Substantially Equivalent	NASIFF ASSOC., INC.
K912183	TYPE 9050/NEO	Jun 23, 1992	Substantially Equivalent	S & W MEDICO TEKNIK
K921331	CAMBRIDGE PC/GXT STRESS TEST SYSTEM	May 11, 1992	Substantially Equivalent	HEALTHWATCH, INC.
K914206	ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST	Mar 30, 1992	Substantially Equivalent	KARDIOSIS LTD. CO.
K920364	ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS	Mar 17, 1992	Substantially Equivalent	BIOSOUND, INC.
K915760	MODIFIED PREDICTOR IIC SIGNAL AVERAGING ECG	Feb 14, 1992	Substantially Equivalent	CORAZONIC CORP.
K915879	HL-300 RECEIVER MODULE	Jan 27, 1992	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K913374	CARDIO PERFECT, CARDIO PERFECT MD	Jan 23, 1992	Substantially Equivalent	CARDIO CONTROL BV
K914974	MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST	Dec 19, 1991	Substantially Equivalent	MEDTRONIC VASCULAR
K914762	MICRO MED INC. QRS-CARD(TM) OFFICE ECG MONITOR	Dec 05, 1991	Substantially Equivalent	MICROMED
K914725	COORDINATOR, CABLE INPUT	Nov 05, 1991	Substantially Equivalent	CARDIOTRONICS, INC.
K910017	Q4500 STREE TEST MONITOR	Nov 05, 1991	Substantially Equivalent	QUINTON, INC.
K903774	LP-PLUS	Aug 29, 1991	Substantially Equivalent	FIDELITY MEDICAL, INC.
K904355	CARDIOCAP II TM CH-RESP MONITORS	May 23, 1991	Substantially Equivalent	INSTRUMENTARIUM CORP.
K904606	MODEL 405	Mar 01, 1991	Substantially Equivalent	IVY BIOMEDICAL SYSTEMS, INC.
K903524	HORIZON 2000 ST ANALYSIS OPTION	Mar 01, 1991	Substantially Equivalent	MENNEN MEDICAL, INC.
K903671	ATHANS EKG STANDARDIZER	Jan 03, 1991	Substantially Equivalent	ADVANCED MEDICAL CONCEPTS, INC.
K904758	CARDIOFAX ECG-8830A	Dec 13, 1990	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K903722	MICROMED QRS CARD	Dec 05, 1990	Substantially Equivalent	NASIFF ASSOC., INC.
K902368	PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH	Sep 11, 1990	Substantially Equivalent	ESAOTE BIOMEDICA SPA
K901817	FUKUDA DENSHI MODEL FX-3101	Aug 23, 1990	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K901948	CARDISUNY 501BIII	Jul 17, 1990	Substantially Equivalent	GRAHAM-FIELD, INC.
K901947	CARDISUNY 501AB	Jul 17, 1990	Substantially Equivalent	GRAHAM-FIELD, INC.
K901771	SIEMENS SIRECUST 732, PATIENT MONITOR	May 30, 1990	Substantially Equivalent	SIEMENS MEDICAL ELECTRONICS
K897121	QEKG ELECTROCARDIOGRAPH	Apr 30, 1990	Substantially Equivalent	QMED, INC.
K900598	TRAMSCOPE SYSTEM	Apr 26, 1990	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K897029	MODEL ECG100 SIMULATOR	Apr 26, 1990	Substantially Equivalent	DYNATECH/NEVADA, INC.
K901032	PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA	Apr 04, 1990	Substantially Equivalent	ACCUCORE, INC.
K900700	SMU 611 UNIVERSALMONITOR	Apr 03, 1990	Substantially Equivalent	PPG INDUSTRIES, INC.
K896190	CARDIOCAP(TM) CMX-104 MONITOR	Mar 08, 1990	Substantially Equivalent	DATEX DIVISION INSTRUMENTARIUM CORP.
K896772	EKG, ECG KENZ, ECG 303	Feb 26, 1990	Substantially Equivalent	CAMBRIDGE MEDICAL INSTRUMENTS, INC.
K894956	CIRCAMED HOLTER VERSION 4	Feb 05, 1990	Substantially Equivalent	CIRCADIAN, INC.
K900272	NKA MODELS AB-601G AND AB-621G	Jan 31, 1990	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K896064	AMBULATORY CARDIAC MONITOR	Jan 26, 1990	Substantially Equivalent	MONITECH, INC.
K896386	MINIMON 7133B PATIENT MONITOR	Dec 13, 1989	Substantially Equivalent	KONTRON INSTRUMENTS, INC.
K896417	KONTRON KOLORMON 7250 PATIENT MONITOR	Dec 12, 1989	Substantially Equivalent	KONTRON INSTRUMENTS, INC.
K893660	ECG SIMULATOR MODEL ECGPLUS	Dec 05, 1989	Substantially Equivalent	BIO-TEK INSTRUMENTS, INC.
K890875	CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512	Oct 17, 1989	Substantially Equivalent	PPG INDUSTRIES, INC.
K884800	ACTA GENOS ELECTROCARDIOGRAPH	Jun 22, 1989	Substantially Equivalent	PAREXEL INTL. CORP.
K892835	E350 ELECTROCARDIOGRAPH	Jun 01, 1989	Substantially Equivalent	BURDICK CORP.
K890791	SIEMENS SIRECUST 730 PATIENT MONITOR	May 02, 1989	Substantially Equivalent	SIEMENS MEDICAL ELECTRONICS
K884116	TYPE 9040 SYSTEM ATHENA	Apr 26, 1989	Substantially Equivalent	S & W MEDICO TEKNIK
K890481	7610 COLORVIEW SLAVE SCOPE	Mar 31, 1989	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K885177	PHYSIOGARD SM 785	Mar 31, 1989	Substantially Equivalent	ADAM
K884504	ELECTRODE GEL	Mar 09, 1989	Substantially Equivalent	HERBERT STANLEY CO.
K883903	NR2000 CARDIAC MONITOR	Mar 09, 1989	Substantially Equivalent	NIRAD LTD.
K884896	BP-308 MARK II	Feb 23, 1989	Substantially Equivalent	COLIN MEDICAL INSTRUMENTS CORP.
K884662	PATIENT MONITOR MODEL 703	Feb 02, 1989	Substantially Equivalent	IVY BIOMEDICAL SYSTEMS, INC.
K883454	MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH	Jan 25, 1989	Substantially Equivalent	CAMBRIDGE MEDICAL INSTRUMENTS, INC.
K883402	EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)	Jan 17, 1989	Substantially Equivalent	QUINTON, INC.
K884992	FUKUDA DENSHI MODEL FX-1201	Jan 12, 1989	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K884956	CARDIOCAP(TM) CTO-104 MONITOR	Dec 27, 1988	Substantially Equivalent	DATEX DIVISION INSTRUMENTARIUM CORP.
K883468	Q5000 ST/HR SLOPE MODIFICATION	Dec 27, 1988	Substantially Equivalent	QUINTON, INC.
K874326	SYSTEM VI MONITOR	Dec 05, 1988	Substantially Equivalent	AIR-SHIELDS, INC.
K882472	LOGIC 3 ELECTROCARDIOGRAPH	Nov 17, 1988	Substantially Equivalent	CEL-MED CO., INC.
K882254	OEC-7102 ECG/NIBP MONITOR	Nov 09, 1988	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K881055	ECG MONITOR AND RESPIRATION PACER	Aug 19, 1988	Substantially Equivalent	D. E. HOKANSON, INC.
K882197	MINIMON 7131B PATIENT MONITOR	Aug 12, 1988	Substantially Equivalent	KONTRON INSTRUMENTS, INC.
K881475	SYSTEM5RH STATIONARY EXERCISE BICYCLE	Aug 02, 1988	Substantially Equivalent	COMBI CO. LTD., C/O MITSUI & CO. U.S.A., INC.
K880357	OMNIGRAPH 6000	Aug 02, 1988	Substantially Equivalent	TELEMED DIV.
K882198	MINIMON 7132B PATIENT MONITOR	Jul 28, 1988	Substantially Equivalent	KONTRON INSTRUMENTS, INC.
K881939	SIRECUST 1280/1281 & 960/961 PATIENT MONITORS	Jul 18, 1988	Substantially Equivalent	SIEMENS MEDICAL ELECTRONICS
K881328	MODEL 375 ECG	May 18, 1988	Substantially Equivalent	BIRTCHER CORP.
K880595	HORIZON 2000/S 266-XXX-XXX	May 06, 1988	Substantially Equivalent	MENNEN MEDICAL, INC.
K874641	CIRCADIAN STRESS TEST II	Apr 01, 1988	Substantially Equivalent	CIRCADIAN, INC.
K875057	FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR	Mar 22, 1988	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K872658	MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH	Jan 06, 1988	Substantially Equivalent	DEL MAR AVIONICS
K872548	FITNESS RECUMBENT ERGOMETER, MODEL FT1400	Dec 15, 1987	Substantially Equivalent	INVACARE CORP.
K871993	MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH	Nov 23, 1987	Substantially Equivalent	CAMBRIDGE MEDICAL INSTRUMENTS, INC.
K873584	MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR	Oct 26, 1987	Substantially Equivalent	QUINTON, INC.
K873346	MODEL 2240 SLAVE SCOPE	Oct 07, 1987	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K864614	LP-3 ELECTROCARDIOGRAPH	Jun 16, 1987	Substantially Equivalent	FIDELITY MEDICAL, INC.
K871239	ACUSON PHYSIOLOGICAL CONTROL MODULE	Jun 05, 1987	Substantially Equivalent	ACUSON COMPUTED SONOGRAPHY
K870926	C150-P ECG CABLES	May 21, 1987	Substantially Equivalent	DESCO INDUSTRIES, INC.
K870880	EK10 ELECTROCARDIOGRAPH	Apr 09, 1987	Substantially Equivalent	BURDICK CORP.
K864504	Q5000 STRESS TEST MONITOR	Apr 09, 1987	Substantially Equivalent	QUINTON, INC.
K864704	CARDIAN III CR6A	Mar 20, 1987	Substantially Equivalent	CARDIAC RECORDERS, LTD.
K864465	CARDIOVIT AT-6	Mar 20, 1987	Substantially Equivalent	SCHILLER CORP.
K864843	HORIZON 1100 CARDIAC MONITOR	Mar 16, 1987	Substantially Equivalent	MENNEN MEDICAL, INC.
K870380	MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03	Mar 11, 1987	Substantially Equivalent	HEWLETT-PACKARD CO.
K864580	MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM)	Feb 20, 1987	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K865031	ELECTROCARDIOGRAPH	Feb 19, 1987	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K864978	APPLISCOPE	Feb 19, 1987	Substantially Equivalent	GRANDCOR MEDICAL SYSTEMS
K864700	Q700 ELECTROCARDIOGRAPH	Feb 19, 1987	Substantially Equivalent	QUINTON, INC.
K863100	CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR	Feb 03, 1987	Substantially Equivalent	HONEYWELL, INC.
K864009	MINGOGRAF 410	Jan 12, 1987	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K863914	MODIFICATION TO DYNASCOPE SERIES MONITORS	Jan 06, 1987	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K863535	LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.	Jan 06, 1987	Substantially Equivalent	COMPUTERIZED MEDICAL SYSTEMS, INC.
K863652	MODEL 456 ELECTROCARDIORECORDER RECORDER	Dec 10, 1986	Substantially Equivalent	DEL MAR AVIONICS
K863030	630C ELECTROCARDIOGRAPH	Nov 20, 1986	Substantially Equivalent	QUINTON, INC.
K862553	ECG MODULE	Nov 07, 1986	Substantially Equivalent	ELSCINT, INC.
K860734	SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR	Nov 06, 1986	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K860646	PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART	Oct 16, 1986	Substantially Equivalent	ANALOGIC CORP.
K862951	SPACELABS SERIES 90700 PATIENT MONITORS	Sep 23, 1986	Substantially Equivalent	SPACELABS, INC.
K863116	CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)	Sep 17, 1986	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K861851	SIEMENS-ELEMA (SICARD-P)	Aug 28, 1986	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K861850	BURDICK DIVISION (E-500)	Aug 28, 1986	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K862748	MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION	Aug 25, 1986	Substantially Equivalent	CAMBRIDGE MEDICAL INSTRUMENTS, INC.
K860973	CIRCADIAN STRESS TEST SYSTEM	Aug 25, 1986	Substantially Equivalent	CIRCADIAN, INC.
K862544	KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH	Aug 06, 1986	Substantially Equivalent	SUZUKEN CO., LTD.
K861281	MICROCOR E.C.G. MONITOR WITH A.C. ADAPTER	Aug 01, 1986	Substantially Equivalent	MICROCOR, INC.
K862381	FUTUREMED ECG SYSTEM 500	Jul 17, 1986	Substantially Equivalent	FUTUREMED DIV. OF FUTURE IMPEX CORP.
K855096	SIEMENS SIRECUST MODELS 403P,403-2P & 403N	Jul 15, 1986	Substantially Equivalent	ANALOGIC CORP.
K861992	MODEL 43200A CARDIAC MONITOR	Jun 09, 1986	Substantially Equivalent	HEWLETT-PACKARD CO.
K861067	PARAGON 420, CARDIAC MONITOR	Jun 05, 1986	Substantially Equivalent	LIFE SENSING INSTRUMENT COMPANY, INC.
K861359	CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM	May 16, 1986	Substantially Equivalent	HEWLETT-PACKARD CO.
K860636	FASTRACE III, ECG ELECTRODE	May 09, 1986	Substantially Equivalent	ANDOVER MEDICAL, INC.
K860790	BIOMECCA CARETAKER 1000 & 2000	May 08, 1986	Substantially Equivalent	BIOMECCA AUSTRALIA LTD.
K854840	PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A	May 07, 1986	Substantially Equivalent	IVY BIOMEDICAL SYSTEMS, INC.
K860212	CARDIOFAX ECG-6353	Apr 17, 1986	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K860175	CD-200 CARDIAC MONITOR	Apr 15, 1986	Substantially Equivalent	CARDIO DISPLAY CORP.
K860249	THE HOLTER REPORTER (TM)	Mar 11, 1986	Substantially Equivalent	APPLIED CARDIAC SYSTEMS
K852829	CARDISUNY 501 A	Feb 26, 1986	Substantially Equivalent	ATRIX
K853979	CARDIMAX FX-1164	Feb 06, 1986	Substantially Equivalent	BRENTWOOD INSTRUMENTS, INC.
K854234	ESCORT ECG MONITOR SIEMENS SIRECUST 466	Jan 21, 1986	Substantially Equivalent	MEDICAL DATA ELECTRONICS
K840571	EKG 503A	Dec 30, 1985	Substantially Equivalent	BOSCH HEARING INSTRUMENTS, INC.
K840569	EKG 501 A	Dec 30, 1985	Substantially Equivalent	BOSCH HEARING INSTRUMENTS, INC.
K851662	LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR	Nov 14, 1985	Substantially Equivalent	LOGOS MEDICAL CO., LTD.
K852282	SCHILLER MINISCOPE MS-2 EKG SCOPE	Oct 09, 1985	Substantially Equivalent	ARMSTRONG IND., INC.
K852281	SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER	Oct 09, 1985	Substantially Equivalent	ARMSTRONG IND., INC.
K852181	ELECTROCARDIOGRAPH	Oct 09, 1985	Substantially Equivalent	ARMSTRONG IND., INC.
K852322	VSM-5	Sep 11, 1985	Substantially Equivalent	PHYSIO-CONTROL CORP.
K851643	REMOTE CONTROL MODULE	Sep 09, 1985	Substantially Equivalent	CIRCADIAN, INC.
K852770	CARIOLINE(ELECTROCARDIOGRAPH)	Aug 01, 1985	Substantially Equivalent	REMCO ITALIA S.P.A.
K851633	CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL	Jun 26, 1985	Substantially Equivalent	EATON MEDICAL GROUP
K851044	CARDIOSTAT 3 RECORDER	Jun 26, 1985	Substantially Equivalent	SIEMENS ELEMA AB
K851322	PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH	May 16, 1985	Substantially Equivalent	PAREXEL INTL. CORP.
K850323	TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPH	May 16, 1985	Substantially Equivalent	EATON MEDICAL GROUP
K850322	RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH	May 16, 1985	Substantially Equivalent	EATON MEDICAL GROUP
K850702	CARDIOVIT CS-6 ECG-RECORDER	Apr 25, 1985	Substantially Equivalent	SCHILLER AG
K844392	CARDIOSTAT 1 ECG RECORDER	Apr 11, 1985	Substantially Equivalent	SIEMENS ELEMA AB
K844101	CARDIO-NEC MODEL 365	Apr 09, 1985	Substantially Equivalent	BIRTCHER CORP.
K850454	CARDIO-3 CHANNEL ELECTROCARDIOGRAPH	Mar 01, 1985	Substantially Equivalent	ZIMMER ELEKTROMEDIZIN GMBH
K842944	MONITORING SYSTEM M720	Mar 01, 1985	Substantially Equivalent	BURDICK CORP.
K850021	ELECTROCARDIOGRAPH-ECG CALIPER	Feb 08, 1985	Substantially Equivalent	DEVCOM, INC.
K840869	SURGICAL MODULE 7000 ECG	Feb 06, 1985	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K841254	CARDIOVIT CV-3	Jan 24, 1985	Substantially Equivalent	SCHILLER AG
K844744	CARDIO IV/GXT STRESS TESTING SYSTEM	Jan 23, 1985	Substantially Equivalent	INTL. MEDICAL, INC.
K844470	FUKUDA DENSHI MODEL FCP-220	Jan 10, 1985	Substantially Equivalent	BRENTWOOD INSTRUMENTS, INC.
K843934	MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT	Nov 20, 1984	Substantially Equivalent	FUTURE IMPEX CORP.
K840020	FITNESS LOGGER	Oct 26, 1984	Unknown	BRITT CORP., INC.
K840440	ELECTROCARDIOGRAPH E-340	Aug 03, 1984	Substantially Equivalent	BURDICK CORP.
K841611	QUINTON 901 & 900 HOLTER SCANNER	Aug 02, 1984	Substantially Equivalent	QUINTON, INC.
K833951	E 310 ELECTROCARDIOGRAPH	May 09, 1984	Substantially Equivalent	BURDICK CORP.
K833593	FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN	May 09, 1984	Substantially Equivalent	BRENTWOOD INSTRUMENTS, INC.
K841148	MINI PECG-MODIFICATION	Apr 17, 1984	Substantially Equivalent	INTERSECT SYSTEMS, INC.
K833584	VITAL SIGNS MONITOR 3	Jan 30, 1984	Substantially Equivalent	PHYSIO-CONTROL CORP.
K832888	ECG INTERFERENCE FILTER TF-03	Jan 18, 1984	Substantially Equivalent	LA JOLLA TECHNOLOGY, INC.
K832421	BATTERY-OPERATED ELECTROCARDIOGRAPH	Dec 16, 1983	Substantially Equivalent	SOMATRONIX RESEARCH CORP.
K832050	MORTARA INSTRUMENT #101	Dec 13, 1983	Substantially Equivalent	MORTARA INSTRUMENT, INC.
K832883	MINI-PECG	Dec 06, 1983	Substantially Equivalent	INTERSECT SYSTEMS, INC.
K832227	G-2000	Dec 01, 1983	Substantially Equivalent	EATON MEDICAL GROUP
K833458	CASE-II	Nov 14, 1983	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K833470	PACEMAKER EVALUATION MODULE-330	Nov 07, 1983	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K832184	SIMPLISCRIPTOR EK 31/101 037 16	Oct 31, 1983	Substantially Equivalent	LITTON MEDICAL ELECTRONICS
K832130	MULTISCRIPTOR EK 36/101 047 02,05	Oct 31, 1983	Substantially Equivalent	LITTON MEDICAL ELECTRONICS
K832015	MULTISCRIPTOR EK VARIOUS #43	Oct 31, 1983	Substantially Equivalent	LITTON MEDICAL ELECTRONICS
K832014	MULTISCRIPTOR EK #403 VARIOUS MODEL	Oct 31, 1983	Substantially Equivalent	LITTON MEDICAL ELECTRONICS
K832013	LME PATIENT MONITOR SMS 151	Oct 31, 1983	Substantially Equivalent	LITTON MEDICAL ELECTRONICS
K832212	PATIENT SELECTOR FUNCTION BLOCK	Oct 14, 1983	Substantially Equivalent	HONEYWELL, INC.
K831429	AS 191 ECG TELEMETRY MODULE	Oct 14, 1983	Substantially Equivalent	NARCO SCIENTIFIC
K831878	CARDIO-SCOPE MINI MONITOR	Sep 29, 1983	Substantially Equivalent	W.E. LEDER ENTERPRISES, INC.
K830666	APNEA/BRADYCARDIA MONITOR HB 95	Jul 18, 1983	Substantially Equivalent	HARVEY-BOSTWICK, INC.
K830791	UNIVERSAL MEDDARS SYSTEM	Jun 22, 1983	Substantially Equivalent	ELECTRONICS FOR MEDICINE, INC.
K830566	CONVERTER UNIT FOR ECG TRACE DISPLAY	May 25, 1983	Substantially Equivalent	HONEYWELL, INC.
K823584	FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO-	Dec 30, 1982	Substantially Equivalent	BRENTWOOD INSTRUMENTS, INC.
K823488	ELECTROCARDIOGRAPH #334	Dec 30, 1982	Substantially Equivalent	BIRTCHER CORP.
K823281	MODEL RM 6000, 6100,6200 POLYGRAPH	Dec 22, 1982	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K823529	FULL-DISCLOSURE AMBULATORY ECG SYSTEM	Dec 15, 1982	Substantially Equivalent	CLINICAL DATA, INC.
K823220	COSMOS	Nov 24, 1982	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K822768	ELECTROCARDIOGRAPH (74 DPS) #YM-102	Oct 04, 1982	Substantially Equivalent	SANYO ELECTRIC, INC.
K822582	QUIKPAGE SCANNER	Sep 21, 1982	Substantially Equivalent	AGILENT TECHNOLOGIES
K821758	QUINTON Q, SCAN MODELS 900 & 901	Aug 25, 1982	Substantially Equivalent	QUINTON, INC.
K821888	AUTOMATIC SINGLE CHANNEL ECG #399	Jul 30, 1982	Substantially Equivalent	BIRTCHER CORP.
K821090	CARDI-O-LIFE MODEL 8823	Jul 08, 1982	Substantially Equivalent	AMERTEK
K820014	HOLTER ECG SCANNER	Apr 21, 1982	Substantially Equivalent	LASER SCAN CORP.
K820067	ELECTROENCEPHALOGRAPH ECG-6151	Feb 12, 1982	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K820011	CARDIOSTRESS	Jan 22, 1982	Substantially Equivalent	INSTRUMENTS FOR CARDIAC RESEARCH
K813279	ELECTROCARDIOGRAPH CM3000	Dec 14, 1981	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K813021	FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36	Dec 14, 1981	Substantially Equivalent	BRENTWOOD INSTRUMENTS, INC.
K813022	FUKUDA DENSHI CARDIMAX FK-12	Dec 02, 1981	Substantially Equivalent	BRENTWOOD INSTRUMENTS, INC.
K811950	KENL-ECG	Aug 13, 1981	Substantially Equivalent	SUZUKEN CO., LTD.
K811949	KENL-ECG-3	Aug 13, 1981	Substantially Equivalent	SUZUKEN CO., LTD.
K811341	BIOVISION CARDIAC STROBE	Jul 16, 1981	Substantially Equivalent	CARDIAC IMAGING
K811121	CENTRAL STATION MONITORING SYSTEMS	Jun 30, 1981	Substantially Equivalent	CAMBRIDGE INSTRUMENTS, INC.
K811016	CC-100	May 01, 1981	Substantially Equivalent	ANTHRO-METRICS CORP.
K810988	IBM 5885 DIGITAL ECG ACQUISITION CART	May 01, 1981	Substantially Equivalent	INTL. BUSINESS MACHINES
K810696	PHYSIOLOGIC RECORDER	Mar 27, 1981	Substantially Equivalent	HONEYWELL, INC.
K810154	LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM	Mar 26, 1981	Substantially Equivalent	PHYSIO-CONTROL CORP.
K810357	STRESS TEST SYSTEM	Mar 11, 1981	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K802368	OPTION 301 PACEMAKER EVAL. MODULE MAC-1	Mar 04, 1981	Substantially Equivalent	MARQUETTE ELECTRONICS, INC.
K810176	ECG FUNCTION BLOCK	Feb 25, 1981	Substantially Equivalent	HONEYWELL, INC.
K810263	MICROPROCESSOR CONTROLLED ELECTROCARDIO	Feb 19, 1981	Substantially Equivalent	HONEYWELL, INC.
K810104	ECG ARRHYTHMIA STIMULATOR	Jan 29, 1981	Substantially Equivalent	BELMONT INSTRUMENT CORP.
K802113	SIRECUST 400 SYSTEM PATIENT MONITORING	Jan 22, 1981	Substantially Equivalent	ANALOGIC CORP.
K803309	VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH	Jan 16, 1981	Substantially Equivalent	ADVANCED TECHNOLOGY LABORATORIES, INC.
K802952	MODEL HEC-7 HEART EVALUATION COMPUTER	Jan 07, 1981	Substantially Equivalent	KLUWE CORP.
K802718	MODEL 4700A ELECTROCARDIOGRAPH	Nov 26, 1980	Substantially Equivalent	HEWLETT-PACKARD CO.
K802190	MODEL 633A THREE CHANNEL STRESS TEST	Oct 23, 1980	Substantially Equivalent	QUINTON, INC.
K801677	ELECTROCARDIOGRAPH, MODEL ECG-5503	Aug 07, 1980	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K800659	SCHILLER MSG-1	Apr 08, 1980	Substantially Equivalent	RENESCO INTERNATIONAL, INC.
K800566	CAMBRIDGE VS-550 ELECTROCARDIOGRAPH	Apr 08, 1980	Substantially Equivalent	CAMBRIDGE INSTRUMENTS, INC.
K800593	SIRECUST 311S	Apr 02, 1980	Substantially Equivalent	SIEMENS CORP.
K800492	VSM-1 PHYSIOLOGICAL MONITOR	Mar 18, 1980	Substantially Equivalent	PHYSIO-CONTROL CORP.
K800005	ECG MONITOR OSCILLOSCOPE MODEL OEC-3100	Mar 05, 1980	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K800004	ECG MONITOR OSCILLOSCOPE MODEL OEC-3200	Mar 05, 1980	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K792229	ELECTROCARDIOGRAPH, MODEL ECG-5151	Nov 21, 1979	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K792072	MODEL 685/686 DYNAMIC ELECTROCARDI0-	Nov 05, 1979	Substantially Equivalent	DEL MAR AVIONICS
K791795	COMP-ACT IV	Sep 27, 1979	Substantially Equivalent	MEDCRAFT CORP.
K791201	SCINTISTRESS SYSTEM	Sep 17, 1979	Substantially Equivalent	CAMBRIDGE INSTRUMENTS, INC.
K791540	ELECTROCARDIOGRAPH MODEL ECG-5403	Sep 04, 1979	Substantially Equivalent	NIHON KOHDEN AMERICA, INC.
K791421	MINISCOPE MS-2B ELECTROCARDIOSCOPE	Aug 28, 1979	Substantially Equivalent	RENESCO INTERNATIONAL, INC.
K791420	MINIGRAPH MG-I ELECTROCARDIOGRAPH	Aug 28, 1979	Substantially Equivalent	RENESCO INTERNATIONAL, INC.
K791364	QUINTON MODEL 630 AND 636 ECG DATA CART	Aug 03, 1979	Substantially Equivalent	QUINTON, INC.
K791151	ECG CHANNEL OF DIAGNOSTIC SYSTEM	Jul 30, 1979	Substantially Equivalent	HONEYWELL, INC.
K790939	MODEL 78501A PATIENT MONITORING SYSTEM	Jun 11, 1979	Substantially Equivalent	HEWLETT-PACKARD CO.
K790794	SIEMENS CARDIOSTAT 701	May 31, 1979	Substantially Equivalent	ELMED, INC.
K790869	CARDIO-SLIDECOMP	May 17, 1979	Substantially Equivalent	CREATIVE INSTRUMENTS
K790739	QUINTON MODEL 530X ECG DATA CART	Apr 26, 1979	Substantially Equivalent	QUINTON, INC.
K790691	25-50 EKG RULER	Apr 16, 1979	Substantially Equivalent	MEDICAL ENGINEERING DESIGNS CO., INC.
K790300	META III	Mar 27, 1979	Substantially Equivalent	HITTMAN MEDICAL SYSTEMS
K790233	ELECTROCARDIOGRAPH, AT-300 3 CHANNEL	Feb 08, 1979	Substantially Equivalent	HEALTH TECHNOLOGY LABORATORIES, INC.
K790114	ELECTROCARDIOGRAPH, EK-9	Feb 08, 1979	Substantially Equivalent	BURDICK CORP.
K781679	MONITOR/MINI SCOPE	Dec 12, 1978	Substantially Equivalent	IPCO CORP.
K781054	LIFELINE AMBULATORY	Jul 27, 1978	Substantially Equivalent	IMC
K780307	CARDIAC MINIGRAPH	May 19, 1978	Substantially Equivalent	ARCO MEDICAL PRODUCTS CO.
K780166	STRESS TEST SYSTEM	Feb 21, 1978	Substantially Equivalent	QUINTON, INC.
K780138	EK-670	Feb 17, 1978	Substantially Equivalent	BURDICK CORP.
K771380	ELAPSED TIME INDICATOR MODEL 21361A	Nov 03, 1977	Substantially Equivalent	HEWLETT-PACKARD CO.
K770832	PORTASCOPE II	Jun 03, 1977	Substantially Equivalent	MENNEN GREATBATCH ELECTONICS
K770760	MONITOR, PORTABLE, PATIENT, G.E.	May 06, 1977	Substantially Equivalent	GENERAL ELECTRIC CO.
K770366	ISOLATED ELECTROCARDIOGRAPH MODEL 1207	Mar 01, 1977	Substantially Equivalent	ELECTRONICS FOR MEDICINE, INC.
K761023	SIMULATOR, 10 LEAD ECG	Jan 31, 1977	Substantially Equivalent	BIRTCHER CORP.
K770037	ELECTROCARDIOGRAPH MODEL 344	Jan 14, 1977	Substantially Equivalent	BIRTCHER CORP.
K761198	MODEL 3044 3-CHANNEL STRESS TEST SYSTEM	Dec 09, 1976	Substantially Equivalent	CAMBRIDGE INSTRUMENTS, INC.
K761014	CARDIART 108T/313	Dec 06, 1976	Substantially Equivalent	CONWAY ELECTRONIC ENTERPRISES LTD.
K760271	ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS)	Nov 15, 1976	Substantially Equivalent	BURDICK CORP.
K760854	THREE-CHANNEL STRESS TEST SYSTEM (M633)	Nov 12, 1976	Substantially Equivalent	QUINTON, INC.
K760272	CIRCUIT, PRINTED, SERVO-MECHANISM	Nov 12, 1976	Substantially Equivalent	BURDICK CORP.
K760268	ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.	Nov 12, 1976	Substantially Equivalent	BURDICK CORP.
K760926	ELECTROCARDIOGRAPH (MODEL VS-4B)	Nov 09, 1976	Substantially Equivalent	CAMBRIDGE INSTRUMENTS, INC.
K760266	MONITOR, ELECTROCARDIOSCOPE	Oct 13, 1976	Substantially Equivalent	BURDICK CORP.
K760677	LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5)	Oct 05, 1976	Substantially Equivalent	PHYSIO-CONTROL CORP.
K760612	SPACELABS SERIES 1000	Sep 21, 1976	Substantially Equivalent	SPACELABS, INC.
K760542	ELECTROCARDIOGRAPH (#1505A)	Sep 09, 1976	Substantially Equivalent	HEWLETT-PACKARD CO.
K760510	MONITORING SYSTEM, REHABILITATION	Aug 30, 1976	Substantially Equivalent	MEDCRAFT CORP.
K760465	STRESS SYSTEM, 3-CHANNEL (#21127A)	Aug 30, 1976	Substantially Equivalent	HEWLETT-PACKARD CO.
K760463	STRESS SYSTEM, SINGLE-CHANNEL (#21125)	Aug 30, 1976	Substantially Equivalent	HEWLETT-PACKARD CO.
K760265	ELCTROCARDIOGRAPH, EK-6	Aug 23, 1976	Substantially Equivalent	BURDICK CORP.
K760150	MONITOR, PATIENT (MODEL 78331A)	Jul 19, 1976	Substantially Equivalent	HEWLETT-PACKARD CO.

FEI Numbers

This FDA classification entry is associated with 184 FEI numbers. Click on an entry to view related FDA registrations.

1000114111: 152 registrations

1000122786: 38 registrations

1000263641: 25 registrations

1000271197: 56 registrations

1218950: 64 registrations

1219324: 17 registrations

1220477: 911 registrations

1220908: 21 registrations

1316463: 77 registrations

1319390: 3 registrations

1450057: 48 registrations

1523530: 22 registrations

1930027: 40 registrations

2024089: 3 registrations

2080783: 62 registrations

2081230: 3 registrations

2084041: 1 registration

2182208: 127 registrations

2433214: 10 registrations

2921581: 14 registrations

2995: 12 registrations

3000126629: 658 registrations

3000130829: 2 registrations

3000215024: 28 registrations

3000957797: 33 registrations

3001149827: 6 registrations

3001373226: 16 registrations

3001570235: 18 registrations

3002087856: 55 registrations

3002737156: 19 registrations

3002806783: 51 registrations

3002807019: 28 registrations

3002807167: 118 registrations

3002807674: 11 registrations

3002807720: 63 registrations

3002807739: 45 registrations

3002807992: 19 registrations

3002808182: 20 registrations

3003174284: 9 registrations

3003190524: 99 registrations

3003263092: 14 registrations

3003294644: 7 registrations

3003513129: 145 registrations

3003591740: 20 registrations

3003622639: 26 registrations

3003647588: 6 registrations

3003681187: 15 registrations

3003708031: 10 registrations

3003832357: 8 registrations

3003857828: 7 registrations

3003971136: 58 registrations

3004035727: 27 registrations

3004072282: 26 registrations

3004145393: 98 registrations

3004186703: 2 registrations

3004415095: 54 registrations

3004582233: 2 registrations

3005269793: 24 registrations

3005488716: 1 registration

3005521864: 2 registrations

3005569927: 55 registrations

3005783425: 35 registrations

3005877899: 47 registrations

3006087789: 47 registrations

3006146787: 9 registrations

3006173899: 1 registration

3006371704: 52 registrations

3006979678: 25 registrations

3007029079: 21 registrations

3007048291: 8 registrations

3007134734: 51 registrations

3007184699: 20 registrations

3007305624: 17 registrations

3007384703: 1 registration

3007413079: 4 registrations

3007513035: 22 registrations

3007734888: 57 registrations

3007770164: 9 registrations

3007836437: 41 registrations

3008164770: 5 registrations

3008293988: 6 registrations

3008457078: 5 registrations

3008483389: 17 registrations

3008505660: 24 registrations

3008642652: 5 registrations

3008716327: 5 registrations

3008717264: 40 registrations

3008729547: 71 registrations

3008794078: 14 registrations

3008820594: 12 registrations

3008881835: 7 registrations

3008921101: 2 registrations

3009077524: 178 registrations

3009183442: 11 registrations

3009349030: 1 registration

3009443693: 11 registrations

3009471886: 17 registrations

3009617712: 165 registrations

3009715978: 19 registrations

3009735945: 3 registrations

3009831876: 17 registrations

3010071455: 5 registrations

3010082909: 44 registrations

3010089768: 2 registrations

3010157426: 51 registrations

3010342616: 2 registrations

3010350335: 9 registrations

3010381606: 44 registrations

3010390468: 36 registrations

3010390940: 22 registrations

3010536822: 8 registrations

3010698831: 8 registrations

3010806736: 2 registrations

3010838917: 39 registrations

3011200896: 8 registrations

3011235999: 3 registrations

3011353843: 55 registrations

3011359729: 3 registrations

3011651230: 8 registrations

3011721071: 6 registrations

3011861727: 5 registrations

3012027770: 10 registrations

3012250536: 9 registrations

3012302888: 33 registrations

3012359877: 31 registrations

3012404027: 3 registrations

3012421607: 606 registrations

3012494290: 762 registrations

3012516456: 3 registrations

3012528160: 30 registrations

3013188547: 138 registrations

3013250653: 1 registration

3013500228: 47 registrations

3013501110: 54 registrations

3013557562: 654 registrations

3013596024: 49 registrations

3013689228: 11 registrations

3013757696: 7 registrations

3013896610: 16 registrations

3014449259: 8 registrations

3014522540: 5 registrations

3014574535: 1 registration

3014579161: 117 registrations

3014848734: 12 registrations

3015134004: 11 registrations

3015134086: 9 registrations

3015142815: 24 registrations

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