Product Code: DQK FDA class 2 21 CFR 870.1425

Computer, Diagnostic, Programmable

Cardiovascular

The Programmable Diagnostic Computer is a cardiovascular computing device capable of processing and analyzing physiological data from multiple inputs to assist clinicians in cardiovascular diagnosis and patient management. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQK and it is regulated under 21 CFR 870.1425 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

430

FEI Numbers

178

Registration Numbers

178

Unique Applicants

189

Years Active

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Basic Information

Product Code: DQK
Device Class: FDA class 2
Regulation Number: 870.1425
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 430 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253088	OneStim-DUO Cardiac Stimulator (MP5003-4CO)	Jun 12, 2026	Substantially Equivalent	Micropace Pty, Ltd.
K261329	Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)	Jun 10, 2026	Substantially Equivalent	Centerline Biomedical
K252859	ZEUS Platform (FG0501US)	May 29, 2026	Substantially Equivalent	iRhythm Technologies, Inc.
K260212	EnSite X EP System	Apr 20, 2026	Substantially Equivalent	ABBOTT MEDICAL
K253861	ACORYS MAPPING SYSTEM	Apr 13, 2026	Substantially Equivalent	Corify Care S.L
K253473	Synchrony	Apr 01, 2026	Substantially Equivalent	Stereotaxis, Inc.
K253186	HemoSphere Nano Monitor (HSNANO1)	Feb 24, 2026	Substantially Equivalent	Edwards Lifesciences, LLC
K252972	CARTO 3 EP Navigation System V8.4	Feb 20, 2026	Substantially Equivalent	Biosense Webster, Inc.
K254089	IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)	Feb 17, 2026	Substantially Equivalent	Centerline Biomedical, Inc.
K251591	Holter ECG and ABP system (HolterABP)	Feb 09, 2026	Substantially Equivalent	Edan Instruments, Inc.
K251218	SafeBeat Rx App	Feb 06, 2026	Substantially Equivalent	SafeBeat Rx, Inc.
K252164	NorthStar Mapping System	Jan 28, 2026	Substantially Equivalent	Imricor Medical Systems
K254085	CARTO 3 EP Navigation System V9.0 with PIU Plus	Jan 18, 2026	Substantially Equivalent	Biosense Webster, Inc.
K253733	STAR Apollo Mapping System	Dec 19, 2025	Substantially Equivalent	Rhythm AI, Ltd.
K252533	HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)	Dec 18, 2025	Substantially Equivalent	Edwards Lifesciences
K253141	DeepRhythmAI	Dec 11, 2025	Substantially Equivalent	Medicalgorithmics S.A.
K252429	Vektor Computational ECG Mapping System (vMap®)	Dec 04, 2025	Substantially Equivalent	Vektor Medical, Inc.
K252645	LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub	Oct 24, 2025	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K252238	CoroFlow Cardiovascular System	Oct 24, 2025	Substantially Equivalent	Coroventis Research AB
K253034	HemoSphere Stream Module	Oct 21, 2025	Substantially Equivalent	Edwards Lifesciences
K252013	EnSite X EP System	Sep 25, 2025	Substantially Equivalent	ABBOTT MEDICAL
K251518	Volta AF-Xplorer II	Sep 12, 2025	Substantially Equivalent	Volta Medical
K251463	EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)	Sep 04, 2025	Substantially Equivalent	ABBOTT MEDICAL
K252302	CARTO 3 EP Navigation System V8.1	Aug 22, 2025	Substantially Equivalent	Biosense Webster, Inc.
K251234	EnSite X EP System	Jul 30, 2025	Substantially Equivalent	ABBOTT MEDICAL
K243781	HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)	Jul 23, 2025	Substantially Equivalent	Edwards Lifesciences
K250747	Globe® Pulsed Field System	Jun 25, 2025	Substantially Equivalent	Kardium, Inc.
K250749	PhysCade System	Jun 04, 2025	Substantially Equivalent	Physcade, Inc.
K251344	OptiMap System	May 28, 2025	Substantially Equivalent	Boston Scientific Corporation
K250932	DeepRhythmAI	May 27, 2025	Substantially Equivalent	Medicalgorithmics S.A.
K243812	Volta AF-Xplorer	May 09, 2025	Substantially Equivalent	Volta Medical
K242129	VitalRhythm	Apr 17, 2025	Substantially Equivalent	Vitalconnect, Inc.
K243842	Intra-Operative Positioning System (IOPS®)	Mar 06, 2025	Substantially Equivalent	Centerline Biomedical, Inc.
K243312	CER-S	Feb 20, 2025	Substantially Equivalent	Cardiocalm Srl
K243892	Affera Integrated Mapping System	Jan 17, 2025	Substantially Equivalent	Medtronic, Inc.
K243540	Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)	Dec 12, 2024	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K243435	Magnetic Localization Patch Kit (AFR-00021)	Dec 05, 2024	Substantially Equivalent	Medtronic, Inc.
K241197	DeepRhythmAI	Dec 04, 2024	Substantially Equivalent	Medicalgorithmics S.A.
K241828	Affera Integrated Mapping System; Impedance Localization Patch Kit	Nov 01, 2024	Substantially Equivalent	Medtronic, Inc.
K242133	Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)	Oct 11, 2024	Substantially Equivalent	Centerline Biomedical, Inc.
K241227	RHYTHMIA HDx Mapping System	Aug 29, 2024	Substantially Equivalent	Boston Scientific Corporation
K233755	HeartKey® Rhythm	Aug 16, 2024	Substantially Equivalent	B-Secur Limited
K242016	EnSite X EP System	Aug 09, 2024	Substantially Equivalent	ABBOTT MEDICAL
K240509	STAR Apollo Mapping System	Jul 26, 2024	Substantially Equivalent	Rhythm AI, Ltd.
K241243	Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)	Jul 24, 2024	Substantially Equivalent	Centerline Biomedical, Inc.
K233326	Merge Hemo, Model RCSV2	Jun 21, 2024	Substantially Equivalent	Merge Healthcare Incorporated
K233853	LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub	Mar 14, 2024	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K233943	Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)	Mar 08, 2024	Substantially Equivalent	Medtronic, Inc.
K231870	CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System	Dec 13, 2023	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K233160	NeuTrace EP Mapping System v.2.1	Nov 25, 2023	Substantially Equivalent	Anumana, Inc.
K232294	HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)	Oct 31, 2023	Substantially Equivalent	Edwards Lifesciences, LLC
K232616	Volta AF-Xplorer	Sep 27, 2023	Substantially Equivalent	Volta Medical
K230884	AVVIGO'+ Multi-Modality Guidance System	Sep 26, 2023	Substantially Equivalent	Boston Scientific Corporation
K223812	Sensis Vibe (VD15)	Sep 15, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K231207	CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)	Sep 07, 2023	Substantially Equivalent	Biosense Webster, Inc.
K230579	Smart Wedge algorithm	Aug 18, 2023	Substantially Equivalent	Edwards Lifesciences, LLC
K231415	EnSite X EP System	Aug 10, 2023	Substantially Equivalent	ABBOTT MEDICAL
K223787	ECGenius System	Aug 04, 2023	Substantially Equivalent	Cath Vision Aps
K231620	Nuubo Smart	Aug 01, 2023	Substantially Equivalent	Smart Solutions Technologies SL
K231035	FusedCO Algorithm	Jul 12, 2023	Substantially Equivalent	Edwards Lifesciences, LLC
K231091	AcQMap High Resolution Imaging and Mapping System	Jul 10, 2023	Substantially Equivalent	Acutus Medical, Inc.
K230309	Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)	Jun 21, 2023	Substantially Equivalent	Centerline Biomedical, Inc.
K223865	HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor	Jun 09, 2023	Substantially Equivalent	Edwards Lifesciences, LLC
K230008	Ablamap® System	Jun 08, 2023	Substantially Equivalent	Ablacon, Inc.
K223918	AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub	Jun 08, 2023	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K230606	AcQMap® High Resolution Imaging and Mapping System	May 02, 2023	Substantially Equivalent	Acutus Medical, Inc.
K223733	CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4	Feb 16, 2023	Substantially Equivalent	Biosense Webster, Inc.
K222389	ZEUS System	Feb 15, 2023	Substantially Equivalent	iRhythm Technologies, Inc.
K223516	VX1+	Jan 21, 2023	Substantially Equivalent	Volta Medical
K211557	EndoPATx	Dec 29, 2022	Substantially Equivalent	Itamar Medical , Ltd.
K223094	EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License	Dec 27, 2022	Substantially Equivalent	ABBOTT MEDICAL
K220786	STAR Apollo Mapping System	Dec 01, 2022	Substantially Equivalent	Rhythm Al, Ltd.
K221704	HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)	Nov 22, 2022	Substantially Equivalent	Edwards Lifesciences, LLC
K223127	HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable	Nov 07, 2022	Substantially Equivalent	Edwards Lifeciences, LLC
K212493	KODEX EPD System 1.5.0	Oct 24, 2022	Substantially Equivalent	Philips Medical Systems Nederland, B.V. (Pmsn)
K222209	AcQMap High Resolution Imaging and Mapping System	Oct 17, 2022	Substantially Equivalent	Acutus Medical, Inc.
K221213	EnSite X EP System	Aug 18, 2022	Substantially Equivalent	Abbott
K221112	CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)	Aug 17, 2022	Substantially Equivalent	Biosense Webster, Inc.
K210822	DeepRhythmAI	Jul 27, 2022	Substantially Equivalent	Medicalgorithmics S.A.
K213409	ZEUS System (Zio Watch)	Jul 19, 2022	Substantially Equivalent	iRhythm Technologies, Inc.
K220784	AcQMap High Resolution Imaging and Mapping System	Jul 01, 2022	Substantially Equivalent	Acutus Medical, Inc.
K213682	HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote	Jun 22, 2022	Substantially Equivalent	Edwards Lifesciences, LLC
K220306	ECGenius System	May 03, 2022	Substantially Equivalent	Cath Vision Aps
K220243	Ultiri Measurement System	Apr 30, 2022	Substantially Equivalent	ABBOTT MEDICAL
K212662	AliveCor QT Service	Apr 26, 2022	Substantially Equivalent	AliveCor, Inc.
K213861	CER-S	Apr 25, 2022	Substantially Equivalent	Cardiocalm Srl
K213972	Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX	Feb 17, 2022	Substantially Equivalent	Ge Healthcare Information Technologies, Inc.
K202094	Cardiovascular Suite 4.2.1	Jan 11, 2022	Substantially Equivalent	Quipu S.R.L
K213364	EnSite X EP System	Nov 11, 2021	Substantially Equivalent	ABBOTT MEDICAL
K211546	Vektor Computational ECG Mapping System (vMap)	Nov 09, 2021	Substantially Equivalent	Vektor Medical, Inc.
K210543	IM007	Nov 03, 2021	Substantially Equivalent	Implicity, Inc.
K213264	CARTO 3 EP Navigation System Version 7.2	Oct 29, 2021	Substantially Equivalent	Biosense Webster, Inc.
K212061	EnSite X EP System	Oct 22, 2021	Substantially Equivalent	Abbott
K212490	AVVIGO Guidance System II	Oct 20, 2021	Substantially Equivalent	Boston Scientific Corporation
K203084	Ablamap Software	Aug 31, 2021	Substantially Equivalent	Ablacon, Inc.
K212345	AcQMap High Resolution Imaging and Mapping System	Aug 27, 2021	Substantially Equivalent	Acutus Medical, Inc.
K201094	iMap 3D Mapping & Navigation System (iMap System)	Aug 16, 2021	Substantially Equivalent	Cardionxt, Inc.
K210680	AcQMap High Resolution Imaging and Mapping System	Aug 05, 2021	Substantially Equivalent	Acutus Medical, Inc.
K211465	HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform	Jul 08, 2021	Substantially Equivalent	Edwards Lfesciences
K210889	iLab Polaris Multi-Modality Guidance System	Jun 25, 2021	Substantially Equivalent	Boston Scientific Corporation
K203687	HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index	May 28, 2021	Substantially Equivalent	Edwards Lifesciences, LLC
K202527	Zio ECG Utilization Software (ZEUS) System	May 21, 2021	Substantially Equivalent	iRhythm Technologies, Inc.
K201921	Spacelabs Lifescreen PRO Analyzer	Mar 26, 2021	Substantially Equivalent	Spacelabs Healthcare, Ltd.
K210392	WorkMate Claris System	Mar 11, 2021	Substantially Equivalent	Abbott
K201081	AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter	Dec 17, 2020	Substantially Equivalent	Philips Medical System Nederland B.V.
K202189	Graffiti	Dec 08, 2020	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K201015	AcQMap High Resolution Imaging and Mapping System	Dec 01, 2020	Substantially Equivalent	Acutus Medical, Inc.
K202066	EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled	Nov 25, 2020	Substantially Equivalent	ABBOTT MEDICAL
K200484	CARTO® 3 EP Navigation System with Signal Processing Unit	Nov 25, 2020	Substantially Equivalent	Biosense Webster, Inc.
K201060	Cordiana Dx16	Nov 16, 2020	Substantially Equivalent	Cordiana Medical Informatics AG
K201881	CoroFlow Cardiovascular System	Nov 13, 2020	Substantially Equivalent	Coroventis Research AB
K201985	KardiaAI	Nov 12, 2020	Substantially Equivalent	AliveCor, Inc.
K201446	HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module	Oct 01, 2020	Substantially Equivalent	Edwards Lifesiences, LLC
K201298	VX1	Sep 16, 2020	Substantially Equivalent	Volta Medical
K200313	VIVO	Sep 14, 2020	Substantially Equivalent	Catheter Precision, Inc.
K201713	AVVIGO Guidance System	Jul 23, 2020	Substantially Equivalent	Boston Scientific Corporation
K201181	EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System	Jun 26, 2020	Substantially Equivalent	ABBOTT MEDICAL
K201148	EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License	Jun 26, 2020	Substantially Equivalent	ABBOTT MEDICAL
K201178	iLab Polaris Multi-Modality Guidance System	May 29, 2020	Substantially Equivalent	Boston Scientific
K193013	AcQMap High Resolution Imaging and Mapping System	Feb 11, 2020	Substantially Equivalent	Acutus Medical, Inc.
K192438	Rhythmia HDxTM Mapping System	Nov 27, 2019	Substantially Equivalent	Boston Scientific Corporation
K191392	AcQMap High Resolution Imaging and Mapping System	Sep 06, 2019	Substantially Equivalent	Acutus Medical, Inc.
K190205	HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module	Aug 29, 2019	Substantially Equivalent	Edwards Lifesciences, LLC
K190593	Zio XT ECG Monitoring System, Zio AT ECG Monitoring System	Aug 23, 2019	Substantially Equivalent	iRhythm Technologies, Inc.
K191660	CARTO 3 EP Navigation System, Version 7.1 and Accessories	Jul 20, 2019	Substantially Equivalent	Biosense Webster, Inc.
K191008	iLab Polaris Multi-Modality Guidance System	Jul 02, 2019	Substantially Equivalent	Boston Scientific Corporation
K190106	Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle	Jun 24, 2019	Substantially Equivalent	Centerline Biomedical, Inc.
K183195	VIVO	Jun 14, 2019	Substantially Equivalent	Catheter Precision, Inc.
K191089	Edwards Pressure Cable	Jun 13, 2019	Substantially Equivalent	Edwards Lifesciences, LLC
K190131	AcQMap High Resolution Imaging and Mapping System	Apr 02, 2019	Substantially Equivalent	Acutus Medical, Inc.
K181823	KardiaAI	Mar 11, 2019	Substantially Equivalent	AliveCor, Inc.
K182344	RhythmAnalytics	Mar 07, 2019	Substantially Equivalent	Biofourmis Singapore Pte., Ltd.
K183266	EP-TRACER System	Mar 01, 2019	Substantially Equivalent	Schwarzer Cardiotek GmbH
K183099	QUANTIEN Measurement System	Feb 28, 2019	Substantially Equivalent	St. Jude Medical (Now Abbott Medical)
K181577	AcQMap High Resolution Imaging and Mapping System	Feb 07, 2019	Substantially Equivalent	Acutus Medical, Inc.
K183128	EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2	Dec 12, 2018	Substantially Equivalent	Abbott
K180432	AI-ECG Platform	Nov 19, 2018	Substantially Equivalent	Shenzhen Carewell Electronics., Ltd.
K180881	HemoSphere Advanced Monitor, HemoSphere Pressure Cable	Nov 16, 2018	Substantially Equivalent	Edwards Lifesciences, LLC
K181918	CardioInsight Cardiac Mapping System	Nov 08, 2018	Substantially Equivalent	Medtronic, Inc.
K180940	KODEX EPD System	Oct 24, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K182644	EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2	Oct 19, 2018	Substantially Equivalent	Abbott
K181502	Zio AT ECG Monitoring System, ZEUS System	Aug 29, 2018	Substantially Equivalent	iRhythm Technologies, Inc.
K173978	CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module	Aug 24, 2018	Substantially Equivalent	Biosense Webster, Inc.
K180805	Pure EP	Aug 08, 2018	Substantially Equivalent	Biosig Technologies
K181720	Epiphany Cardio Server Mobile	Jul 30, 2018	Substantially Equivalent	Epiphany Healthcare, LLC
K173837	RHYTHMIA HDx Mapping System (with software Version 2.0)	Jul 25, 2018	Substantially Equivalent	Boston Scientific Corporation
K173977	CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module	Jun 14, 2018	Substantially Equivalent	Biosense Webster, Inc.
K180238	CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT	Jun 01, 2018	Substantially Equivalent	Biosense Webster, Inc.
K172396	EnSite Velocity Cardiac Mapping System v5.2	Apr 23, 2018	Substantially Equivalent	St Jude Medical
K170948	AcQMap High Resolution Imaging and Mapping System	Oct 16, 2017	Substantially Equivalent	Acutus Medical, Inc.
K171583	RhythmView Workstation	Sep 01, 2017	Substantially Equivalent	Abbott Electrophysiology
K172182	QUANTIEN Measurement System	Aug 18, 2017	Substantially Equivalent	St. Jude Medical (Now Part of the Abbott Medical)
K170600	CARTO 3 EP Navigation System, Version 6.0 and Accessories	Jul 25, 2017	Substantially Equivalent	Biosense Webster, Inc.
K163381	HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable	Apr 14, 2017	Substantially Equivalent	Edwards Lifesciences, LLC
K162023	CardioDay V2.5	Mar 24, 2017	Substantially Equivalent	Getemed Medizin- Und Informationstechnik AG
K162793	RHYTHMIA HDx Mapping System	Mar 10, 2017	Substantially Equivalent	Boston Scientific Corporation
K162643	MediGuide Technology System	Dec 13, 2016	Substantially Equivalent	St Jude Medical
K160218	AutoMark Module	Dec 13, 2016	Substantially Equivalent	St Jude Medical
K160210	EnSite Precision Cardiac Mapping System v2.0	Dec 13, 2016	Substantially Equivalent	St Jude Medical
K162440	CardioInsight Cardiac Mapping System	Nov 04, 2016	Substantially Equivalent	Cardioinsight Technologies, Inc.
K160187	Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0	Oct 21, 2016	Substantially Equivalent	St Jude Medical
K160186	EnSite Velocity Surface Electrode Kit	Oct 07, 2016	Substantially Equivalent	St Jude Medical
K153654	Sentry WEB SmartInterp	Sep 16, 2016	Substantially Equivalent	Carefusion Germany 234 GmbH
K161465	CardioConfirm	Sep 03, 2016	Substantially Equivalent	Mortara Instrument, Inc.
K161240	Rhythm View Workstation (non-streaming)	Aug 10, 2016	Substantially Equivalent	Abbott Electrophysiology
K161245	EP-TRACER System	Aug 05, 2016	Substantially Equivalent	Cardio Tek, BV
K152864	Merge Hemo	Apr 07, 2016	Substantially Equivalent	Merge Healthcare Incorporated
K152881	SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM	Apr 01, 2016	Substantially Equivalent	Spacelabs Healthcare, Ltd.
K152160	Navik 3D	Feb 23, 2016	Substantially Equivalent	Apn Health, LLC
K151787	Holter System	Jan 27, 2016	Substantially Equivalent	Edan Instruments, Inc.
K152993	MUSE Cardiology Information System	Jan 12, 2016	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K151911	WorkMate Claris System, WorkMate Claris System Display Plus	Oct 22, 2015	Substantially Equivalent	St Jude Medical
K151613	iLab Polaris Multi-Modality Guidance System	Oct 06, 2015	Substantially Equivalent	Boston Scientific Corporation
K142349	TM eCloud ECG Analysis System	Sep 21, 2015	Substantially Equivalent	Telemed Solutions, Inc.
K151245	Rhythm View Workstation (non-streaming, steaming option)	Sep 15, 2015	Substantially Equivalent	Topera, Inc.
K150990	ECVUE Mapping System	Jul 02, 2015	Substantially Equivalent	Cardioinsight Technologies, Inc.
K150493	Sensis	Jun 30, 2015	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K143449	ADH 200 Analyzer Software	Jun 26, 2015	Substantially Equivalent	Adams Meditech, LLC
K142901	RhythmView Workstation	Dec 19, 2014	Substantially Equivalent	Topera, Inc.
K142681	ZEUS (ZIO ECG Utilization Service) System	Nov 21, 2014	Substantially Equivalent	iRhythm Technologies, Inc.
K140497	ECVUE MAPPING SYSTEM	Nov 19, 2014	Substantially Equivalent	Cardioinsight Technologies, Inc.
K133916	CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2	Jul 01, 2014	Substantially Equivalent	Biosense Webster, Inc.
K141185	V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM	Jun 06, 2014	Substantially Equivalent	Boston Scientific Corp
K141050	ENSITE VELOCITY SYSTEM	Jun 06, 2014	Substantially Equivalent	St Jude Medical
K133534	MCKESSON CARDIOLOGY ECG MOBILE	Apr 18, 2014	Substantially Equivalent	Mckesson Israel , Ltd.
K134044	EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM	Mar 31, 2014	Substantially Equivalent	Cardio Tek, BV
K132782	CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2	Jan 24, 2014	Substantially Equivalent	Biosense Webster, Inc.
K133305	RHYTHM VIEW WORKSTATION	Dec 16, 2013	Substantially Equivalent	Topera, Inc.
K132437	MARS HOLTER ANALYSIS WORKSTATION	Dec 04, 2013	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K132073	EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE	Sep 09, 2013	Substantially Equivalent	St Jude Medical
K130727	ENSITE VELOCITY SYSTEM	Aug 29, 2013	Substantially Equivalent	St Jude Medical
K130516	CARDIODAY	Aug 23, 2013	Substantially Equivalent	Getemed Medizin- Und Informationstechnik AG
K131812	SENSIS, SENSIS LITE	Jul 25, 2013	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K130750	RHYTHMIA MAPPING SYSTEM	Jul 22, 2013	Substantially Equivalent	Rhythmia Medical, Inc.
K131045	ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE	May 29, 2013	Substantially Equivalent	Cardiac Designs, LLC
K130594	ENSITE VELOCITY SYSTEM	May 03, 2013	Substantially Equivalent	St Jude Medical
K130626	MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS	May 01, 2013	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K123295	RHYTHM VIEW	Apr 24, 2013	Substantially Equivalent	Topera, Inc.
K123984	QUANTIEN MEASUREMENT SYSTEM	Mar 28, 2013	Substantially Equivalent	Radi Medical Systems AB
K130155	MUSE CARDIOLOGY INFORMATION SYSTEM	Mar 01, 2013	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K123466	HEALTHVIEW ECG MANAGER	Dec 20, 2012	Substantially Equivalent	Lumedx
K121638	ST80I STRESS TEST SYSTEM	Jul 18, 2012	Substantially Equivalent	Philips Health Care
K120855	INTELLISPACE ECG	Jun 29, 2012	Substantially Equivalent	Philips Health Care
K120550	CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)	May 07, 2012	Substantially Equivalent	Biosense Webster, Inc.
K113811	V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM	Mar 16, 2012	Substantially Equivalent	C.R. Bard Inc., Bard Electrophysiology Division
K113515	HORIZON CARDIOLOGY ECG MANAGEMENT	Mar 16, 2012	Substantially Equivalent	Mckesson Israel , Ltd.
K120301	MEDIGUIDE TECHNOLOGY	Feb 24, 2012	Substantially Equivalent	St. Jude Medical, Mediguide Navigation Systems
K112688	ENSITE VELOCITY SYSTEM V.3.0	Nov 09, 2011	Substantially Equivalent	St Jude Medical
K111200	MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM	Oct 12, 2011	Substantially Equivalent	GE Healthcare
K112007	CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2	Oct 05, 2011	Substantially Equivalent	Biosense Webster, Inc.
K110878	RHYTHMVIEW (TM)	Sep 23, 2011	Substantially Equivalent	Topera, Inc.
K110001	SPACELABS PATHFINDER SL HOLTER ANALYZER	Jun 14, 2011	Substantially Equivalent	Spacelabs Healthcare, Ltd.
K110132	MUSE CARDIOLOGY INFORMATION SYSTEM	May 25, 2011	Substantially Equivalent	Ge Medical Systems Information Technologies, Inc.
K110746	4D LV-ANALYSIS 3.0	May 24, 2011	Substantially Equivalent	Tomtec Imaging Systems GmbH
K110549	ENSITE VELOCITY SYSTEM	May 05, 2011	Substantially Equivalent	St Jude Medical
K110779	SPACELABS SMART DISCLOSURE SYSTEM	Apr 19, 2011	Substantially Equivalent	Spacelabs Healthcare
K103678	CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM	Feb 16, 2011	Substantially Equivalent	Ge Medical Systems Information Technologies GmbH
K103782	4D MV-ASSESSMENT 2.0	Jan 27, 2011	Substantially Equivalent	Tomtec Imaging Systems GmbH
K103746	CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)	Jan 21, 2011	Substantially Equivalent	Biosense Webster, Inc.
K102905	GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)	Oct 29, 2010	Substantially Equivalent	Mediguide, Ltd.
K101331	LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE	Oct 08, 2010	Substantially Equivalent	C.R. Bard Inc., Bard Electrophysiology Division
K101328	ENSITE VELOCITY SYSTEM	Jul 14, 2010	Substantially Equivalent	St Jude Medical
K101667	ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)	Jul 02, 2010	Substantially Equivalent	St Jude Medical
K093566	CARTO XP EP NAVIGATION SYSTEM, VERSION 10	Jun 18, 2010	Substantially Equivalent	Biosense Webster, Inc.
K101419	ENSITE VELOCITY SYSTEM, MODEL EE3000	Jun 11, 2010	Substantially Equivalent	St Jude Medical
K100362	CAMBRIDGE HEART OEM	Apr 14, 2010	Substantially Equivalent	Cambridge Heart, Inc.
K093942	ENSITE VELOCITY SYSTEM V1.3	Feb 25, 2010	Substantially Equivalent	St Jude Medical
K093092	ODYSSEY WORKSTATION	Jan 21, 2010	Substantially Equivalent	Stereotaxis, Inc.
K093141	MARS HOLTER ANALYSIS WORKSTATION	Dec 29, 2009	Substantially Equivalent	Ge Medical Systems Information Technologies
K093583	EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE	Dec 15, 2009	Substantially Equivalent	St Jude Medical
K093455	CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES	Dec 04, 2009	Substantially Equivalent	Biosense Webster, Inc.
K091781	GUIDED MEDICAL POSITIONING SYSTEM (GMPS)	Oct 16, 2009	Substantially Equivalent	Mediguide, Ltd.
K090017	CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES	Oct 13, 2009	Substantially Equivalent	Biosense Webster, Inc.
K092810	EP-WORKMATE SYSTEM, VERSION 4.2	Oct 09, 2009	Substantially Equivalent	St Jude Medical
K092105	RADIANALYZER XPRESS	Oct 09, 2009	Substantially Equivalent	Radi Medical Systems AB
K091789	CARTO RMT EP NAVIGATION SYSTEM V8	Oct 01, 2009	Substantially Equivalent	Biosense Webster, Inc.
K091165	HORIZON XVU	Aug 07, 2009	Substantially Equivalent	Mennen Medical , Ltd.
K091075	ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM	Jul 21, 2009	Substantially Equivalent	iRhythm Technologies, Inc.
K083328	ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010	May 22, 2009	Substantially Equivalent	St Jude Medical
K083639	MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE	Feb 17, 2009	Substantially Equivalent	Ge Medical Systems Information Technologies
K082421	HEARTSUITE HEMODYNAMICS 7.10	Dec 17, 2008	Substantially Equivalent	Emageon, Inc.
K072752	BP LIMBO XL, BPTANGO XL, BP SALSA XL	Oct 31, 2008	Substantially Equivalent	Datadancer Medical Systems
K082467	ENSITE FUSION DYNAMIC REGISTRATION TOOL	Sep 11, 2008	Substantially Equivalent	St Jude Medical
K081484	HORIZON XVU	Jun 20, 2008	Substantially Equivalent	Mennen Medical , Ltd.
K071818	ENSITE FUSION DYNAMIC REGISTRATION TOOL	Dec 20, 2007	Substantially Equivalent	St Jude Medical
K072502	MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM	Nov 19, 2007	Substantially Equivalent	Ge Medical Systems Information Technologies
K072202	CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)	Nov 19, 2007	Substantially Equivalent	Biosense Webster, Inc.
K072919	VENDYS, MODEL 6000 B B/C	Nov 02, 2007	Substantially Equivalent	Endothelix, Inc.
K071911	CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR	Sep 07, 2007	Substantially Equivalent	Innovision A/S
K071348	EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM	Sep 07, 2007	Substantially Equivalent	Mennen Medical , Ltd.
K060980	VENDYS MODEL 5000 B/BC	Aug 16, 2007	Substantially Equivalent	Endothelix, Inc.
K070240	CARTO XP EP NAVIGATION SYSTEM, VERSION 9	May 04, 2007	Substantially Equivalent	Biosense Webster, Inc.
K070902	MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000	May 01, 2007	Substantially Equivalent	St Jude Medical
K070254	HORIZON SE	Apr 19, 2007	Substantially Equivalent	Mennen Medical , Ltd.
K070706	EP-WORKMATE	Apr 11, 2007	Substantially Equivalent	Ep Medsystems
K063490	SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810	Mar 15, 2007	Substantially Equivalent	Spacelabs Medical, Inc.
K070280	CARDIODAY, VERSION 2.0	Feb 23, 2007	Substantially Equivalent	Getemed Medizin- Und Informationstechnik AG
K063277	MAPMATE	Nov 30, 2006	Substantially Equivalent	Ep Medsystems, Inc.
K061905	HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0	Nov 08, 2006	Substantially Equivalent	Medcon , Ltd.
K063113	EP-WORKMATE	Oct 27, 2006	Substantially Equivalent	Ep Medsystems
K061741	MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM	Sep 15, 2006	Substantially Equivalent	GE Healthcare
K060954	MODIFICATION TO ENSITE SYSTEM, MODEL EE3000	Apr 21, 2006	Substantially Equivalent	St. Jude Medical, Inc.-Endocardial Solutions
K053194	NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE	Mar 09, 2006	Substantially Equivalent	Biosense Webster, Inc.
K051907	INNOCOR	Mar 02, 2006	Substantially Equivalent	Innovision A/S
K052976	DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES	Jan 13, 2006	Substantially Equivalent	GE Healthcare
K053369	MEDILOG DARWIN HOLTER ANALYSIS	Dec 22, 2005	Substantially Equivalent	Huntleigh Healthcare
K052977	DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES	Nov 22, 2005	Substantially Equivalent	GE Healthcare
K052883	CARDIOSERVER	Nov 01, 2005	Substantially Equivalent	Datrix
K042681	CARTO RMT EP NAVIGATION SYSTEM	Sep 29, 2005	Substantially Equivalent	Biosense Webster, Inc.
K051026	MARS HOLTER ANALYSIS WORKSTATION	Jul 19, 2005	Substantially Equivalent	Ge Medical Systems Information Technologies
K051471	CARDIODAY	Jun 29, 2005	Substantially Equivalent	Getemed Medizin- Und Informationstechnik AG
K050093	MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM	May 13, 2005	Substantially Equivalent	Ge Medical Systems Information Technologies
K050561	WINDSURFER	May 04, 2005	Substantially Equivalent	Medcon , Ltd.
K043604	LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE	Apr 29, 2005	Substantially Equivalent	Vivometrics, Inc.
K050225	HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM	Apr 07, 2005	Substantially Equivalent	Cambridge Heart, Inc.
K050614	MUSE CARDIOLOGY INFORMATION SYSTEM	Apr 05, 2005	Substantially Equivalent	Ge Medical Systems Information Technologies
K042999	CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8	Mar 21, 2005	Substantially Equivalent	Biosense Webster, Inc.
K043564	HORIZON ANGIO CATHLAB	Jan 27, 2005	Substantially Equivalent	Mennen Medical , Ltd.
K041031	CARDIOSTATION-100 (CS-100)	Jan 26, 2005	Substantially Equivalent	Us Clover Co.
K042628	MODIFICATION TO: RADIANALYZER, MODEL 12711	Jan 19, 2005	Substantially Equivalent	Radi Medical Systems AB
K042849	CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)	Jan 13, 2005	Substantially Equivalent	Cardiobiomedical Corporation
K033266	VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS	Dec 16, 2004	Substantially Equivalent	Medical Imaging Applications, LLC
K042148	HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES	Dec 03, 2004	Substantially Equivalent	Ge Medical Syst. Information Technologies
K042799	QRS-CARD CARDIOLOGY SUITE	Oct 22, 2004	Substantially Equivalent	Pulse Biomedical, Inc.
K042002	SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER	Oct 20, 2004	Substantially Equivalent	Ela Medical, Inc.
K042493	ENSITE SYSTEM, MODEL EE3000	Oct 15, 2004	Substantially Equivalent	Endocardial Solutions, Inc.
K042463	HOLTER PLUS	Sep 22, 2004	Substantially Equivalent	Rozinn Electronics, Inc.
K032519	ENDO PAT 2000	Nov 12, 2003	Substantially Equivalent	Itamar Medical
K033211	ENSITE SYSTEM	Oct 30, 2003	Substantially Equivalent	Endocardial Solutions, Inc.
K032513	T-WAVE ALTERNANS (TWA) ALGORITHM OPTION	Oct 30, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K032577	MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM	Oct 10, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K030145	GALIX WINTER	Sep 17, 2003	Substantially Equivalent	Galix Biomedical Instrumentation, Inc.
K031970	INFINITY MEGACARE	Sep 09, 2003	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K032038	PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601	Sep 05, 2003	Substantially Equivalent	Quinton, Inc.
K032225	EP-WORKMATE WITH RPM SYSTEM	Aug 20, 2003	Substantially Equivalent	Ep Medsystems
K031561	CARDIOSOFT/CASE CARDIAC TESTING SYSTEM	Aug 01, 2003	Substantially Equivalent	Ge Medical Systems Information Technologies
K031550	REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE	Jul 29, 2003	Substantially Equivalent	Vivometrics, Inc.
K031000	LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0	Jun 03, 2003	Substantially Equivalent	C.R. Bard, Inc.
K030129	MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000	Apr 22, 2003	Unknown	Endocardial Solutions, Inc.
K022596	BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)	Jan 31, 2003	Substantially Equivalent	Clover Hi-Tech, Inc.
K020863	CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM	Jan 09, 2003	Substantially Equivalent	Biosense Webster, Inc.
K023370	CHEETAH I.V.D.S., MODEL 2002P	Dec 24, 2002	Substantially Equivalent	Cheetah Medical, Inc.
K023112	PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9	Dec 17, 2002	Substantially Equivalent	Problem Solving Concepts, Inc.
K023380	T-WAVE ALTERMANS (TWA) ALGORITHM OPTION	Dec 03, 2002	Substantially Equivalent	General Electric Medical Systems Information Techn
K020440	NEWCOR	Dec 03, 2002	Substantially Equivalent	Siemens Medical Systems, Inc.
K022188	RADIANALYZER, MODEL 12710	Oct 03, 2002	Substantially Equivalent	Radi Medical Systems AB
K021495	QIVA	Oct 01, 2002	Substantially Equivalent	Pie Medical Imaging BV
K023015	CARDIS	Sep 25, 2002	Substantially Equivalent	Schwarzer GmbH
K021906	QUINTON Q-CATH, MODEL 000460	Sep 04, 2002	Substantially Equivalent	Quinton, Inc.
K021366	MAC-LAB/CARDIOLAB EP/COMBOLAB	Jul 03, 2002	Substantially Equivalent	General Electric Medical Systems Information Techn
K013032	PHYSIOLOG, SERIES 95000	Jun 04, 2002	Substantially Equivalent	Camtronics, Ltd.
K011903	LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE	Apr 12, 2002	Substantially Equivalent	Vivometrics, Inc.
K013349	ASTRONOMER PLUS SYSTEM	Apr 09, 2002	Substantially Equivalent	Ep Technologies, Inc.
K012825	HEARTTRENDS	Mar 19, 2002	Substantially Equivalent	Lev-El, Ltd.
K020127	SMARTFLOW PULSE TRANSMISSION COEFFICIENT	Feb 14, 2002	Substantially Equivalent	Florence Medical , Ltd.
K012089	CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM	Jan 28, 2002	Substantially Equivalent	Catheffects, LLC
K014108	MAC 5000 ECG ANALYSIS SYSTEM	Jan 10, 2002	Substantially Equivalent	General Electric Medical Systems Information Techn
K013083	CARTO XP EP NAVIGATION SYSTEM	Nov 21, 2001	Substantially Equivalent	Biosense Webster, Inc.
K012206	ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM	Oct 12, 2001	Substantially Equivalent	Cambridge Heart, Inc.
K012947	SMARTFLOW	Oct 02, 2001	Substantially Equivalent	Florence Medical , Ltd.
K012020	RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC	Aug 21, 2001	Substantially Equivalent	Non-Invasive Monitoring Systems, Inc.
K011324	CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM	May 23, 2001	Substantially Equivalent	Cambridge Heart, Inc.
K002817	SYNETEC	May 02, 2001	Substantially Equivalent	Ela Medical, Inc.
K010756	CH 2000 CARDIAC DIAGNOSTIC SYSTEM	Apr 12, 2001	Substantially Equivalent	Cambridge Heart, Inc.
K002869	LOCALISA CARDIAC NAVIGATION SYSTEM	Mar 27, 2001	Substantially Equivalent	Medtronic Surgical Navigation Technologies
K003362	ASTRONOMER+WITH SLD	Mar 01, 2001	Substantially Equivalent	Boston Scientific Corp
K001852	PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE	Feb 21, 2001	Substantially Equivalent	Itamar Medical (C.M.) 1997 , Ltd.
K003492	ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS	Jan 18, 2001	Substantially Equivalent	Cambridge Heart, Inc.
K002137	CATHCOR DESKTOP	Oct 05, 2000	Substantially Equivalent	Siemens Elema AB
K002544	MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM	Sep 13, 2000	Substantially Equivalent	Oxford Instruments
K001369	RESPIEVENTS, VERSION 4.2	Jul 26, 2000	Substantially Equivalent	Non-Invasive Monitoring Systems, Inc.
K001305	MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM	Jun 27, 2000	Substantially Equivalent	General Electric Medical Systems Information Techn
K001592	ECHOCOM, IMAGECOM, DOKUCOM	Jun 16, 2000	Substantially Equivalent	Tomtec Imaging Systems GmbH
K001437	ENSITE 3000 SYSTEM, MODEL EE3000	Jun 07, 2000	Substantially Equivalent	Endocardial Solutions, Inc.
K000248	CARTO EP NAVIGATION SYSTEM	May 05, 2000	Substantially Equivalent	Biosense Webster, Inc.
K000190	MODIFICATION TO CARTO EP NAVIGATION SYSTEM	May 05, 2000	Substantially Equivalent	Biosense Webster, Inc.
K000332	NOGA CARDIAC NAVIGATION SYSTEM	May 04, 2000	Substantially Equivalent	Biosense Webster, Inc.
K994011	EP MEDSYSTEMS, EP-WORKMATE	Mar 23, 2000	Substantially Equivalent	Ep Medsystems, Inc.
K992703	CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800	Mar 21, 2000	Substantially Equivalent	Premier Heart, LLC
K990058	QMS MAPPING SYSTEM,MODEL 2000	Dec 15, 1999	Substantially Equivalent	Cathdata, Inc.
K993729	MODIFICATION TO CARTO EP NAVIGATION SYSTEM	Dec 03, 1999	Substantially Equivalent	Biosense Webster, Inc.
K992479	ENSITE 3000 SYSTEM	Dec 02, 1999	Unknown	Endocardial Solutions, Inc.
K992948	MAC-LAB SYSTEM	Nov 29, 1999	Substantially Equivalent	General Electric Medical Systems Information Techn
K990727	SYNEFLASH & SYNEVIEW	Nov 26, 1999	Substantially Equivalent	Ela Medical, Inc.
K993620	IMPRESARIO	Nov 12, 1999	Substantially Equivalent	Del Mar Medical Systems, LLC
K992968	CARTO EP NAVIGATION SYSTEM	Sep 29, 1999	Substantially Equivalent	Biosense Webster, Inc.
K990494	MODIFICATION OF NOGA	Sep 03, 1999	Substantially Equivalent	Biosense, Inc.
K990956	BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005	Jun 14, 1999	Substantially Equivalent	Biosensor Corp.
K983102	CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000	Apr 12, 1999	Substantially Equivalent	Cambridge Heart, Inc.
K973751	MT-200	Aug 25, 1998	Substantially Equivalent	Schiller America, Inc.
K974546	BIOSENSOR HOLTER MONITOR SYSTEM	Mar 04, 1998	Substantially Equivalent	Biosensor Corp.
K974192	BIOSENSOR HOLTER MONITOR SYSTEM	Mar 04, 1998	Substantially Equivalent	Biosensor Corp.
K970570	NIVP3 (WINDOWS VERSION OF NIVP	Oct 03, 1997	Substantially Equivalent	D. E. Hokanson, Inc.
K962930	SPACELABS MEDICAL ECG ANALYSIS SYSTEM	Apr 25, 1997	Unknown	Spacelabs Medical, Inc.
K952969	EIDOS 5003 HOLTER SYSTEM	Jul 16, 1996	Substantially Equivalent	New Product Development, Inc.
K951902	PATHFINDER 700 HOLTER ANALYZER	Jul 15, 1996	Substantially Equivalent	Reynolds Medical , Ltd.
K950944	AMBULATORY (HOLTER) RECORDING SYSTEM	Jun 18, 1996	Substantially Equivalent	Biosensor Corp.
K961009	STRESSWRITER EXERCISE TESTING SYSTEM	Jun 17, 1996	Substantially Equivalent	Hewlett-Packard Co.
K961063	AS/3 CARDIAC OUTPUT & SVO2 MODULE	May 31, 1996	Substantially Equivalent	Datex Medical Instrumentation, Inc.
K955015	ZYMED HOLTER SCANNER MODEL 2010	Mar 18, 1996	Substantially Equivalent	Zymed Medical Instrumentation
K953127	ACCUSTRESS EXERCISE TESTING SYSTEM	Feb 29, 1996	Substantially Equivalent	Hewlett-Packard Co.
K942852	RESPITRACE PT	Feb 13, 1996	Substantially Equivalent	Non-Invasive Monitoring Systems, Inc.
K942771	RESPIEVENTS	Feb 13, 1996	Substantially Equivalent	Non-Invasive Monitoring Systems, Inc.
K950723	AMBULATORY (HOLTER) RECORDING SYSTEM	Feb 09, 1996	Substantially Equivalent	Biosensor Corp.
K945068	OMEGA CARES SYSTEM	Jan 25, 1996	Substantially Equivalent	J-F Medical Systems Intl., Inc.
K950988	HOLTER 6000	Jan 04, 1996	Substantially Equivalent	Omega Medical Services, Inc.
K954395	CARTO SYSTEM	Dec 21, 1995	Substantially Equivalent	Biosense, Ltd.
K952846	EPICARDIA	Sep 18, 1995	Substantially Equivalent	Medicomp, Inc.
K945985	PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400	Jul 03, 1995	Substantially Equivalent	Burdick, Inc.
K922528	CMS SYSTEM	May 12, 1995	Substantially Equivalent	Micromedical Industries, Ltd.
K952164	EMI MODEL FFF-IA	May 10, 1995	Substantially Equivalent	New York Heart Instruments, Inc.
K930564	HOLTER FOR WINDOWS	Apr 19, 1995	Substantially Equivalent	North East Monitoring, Inc.
K935043	SIEMENS CLINICAL WORK STATION	Apr 07, 1995	Substantially Equivalent	Siemens Medical Electronics
K941762	INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)	Feb 22, 1995	Substantially Equivalent	Hogan & Hartson
K935186	ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY	Jan 03, 1995	Substantially Equivalent	Electrophysiology Systems, Inc.
K942565	ALTAIR-DISC RECORDER	Dec 05, 1994	Substantially Equivalent	Burdick Corp.
K930806	ZYMED HOLTER SCANNER MODEL 2010	Apr 25, 1994	Substantially Equivalent	Agilent Technologies
K931900	COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.	Mar 11, 1994	Substantially Equivalent	Archival Technologies, Inc.
K932954	AVOXIMETER	Dec 27, 1993	Substantially Equivalent	A-Vox Systems, Inc.
K930639	ON-LINE ANALYSIS SYSTEM	Sep 22, 1993	Substantially Equivalent	Softheart, Inc.
K925285	DUALTHERM(R) CARDIAC OUTPUT COMPUTER	Jul 21, 1993	Substantially Equivalent	B. Braun of America, Inc.
K920587	PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS	Jan 15, 1993	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K922171	CENTRA II ANALYSIS SYSTEM	Dec 28, 1992	Substantially Equivalent	Marquette Electronics, Inc.
K921216	OFF-LINE ANALYSIS SYSTEM	Nov 20, 1992	Substantially Equivalent	Softheart, Inc.
K920295	MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)	Aug 18, 1992	Substantially Equivalent	Oxford Medilog, Inc.
K914577	RHYTHMSCAN PRECISION 6000	May 08, 1992	Substantially Equivalent	Precision Health Care Systems, Inc.
K912728	ALTAIR	Feb 27, 1992	Substantially Equivalent	Diagnostic Medical Instruments
K914105	CATHWRITER(TM)	Feb 26, 1992	Substantially Equivalent	Softheart, Inc.
K911615	HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300	Jan 08, 1992	Substantially Equivalent	Diagnostic Monitoring Software
K913193	MODEL 100 CENTRAL STATION	Oct 16, 1991	Substantially Equivalent	Protocol Systems, Inc.
K905248	NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS	Feb 28, 1991	Substantially Equivalent	Advanced Technology Laboratories, Inc.
K905100	HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST	Jan 15, 1991	Substantially Equivalent	Hewlett-Packard Co.
K900814	CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS	Dec 17, 1990	Substantially Equivalent	Intellimetrics Instrument Corp.
K896017	THE OPHTHIMUS SYSTEM	Oct 02, 1990	Substantially Equivalent	Hightech Vision
K902716	PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)	Sep 04, 1990	Substantially Equivalent	Prucka Engineering, Inc.
K892113	Q5000 PC WORKSTATION	May 18, 1989	Substantially Equivalent	Quinton, Inc.
K883152	EP-STAT	Oct 13, 1988	Substantially Equivalent	Coherent Systems, Inc.
K880879	WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION	Jun 02, 1988	Substantially Equivalent	Ppg Industries, Inc.
K881770	EPICARDIA LE/FD	May 31, 1988	Substantially Equivalent	Medicomp, Inc.
K874171	MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM	Feb 05, 1988	Substantially Equivalent	Hewlett-Packard Co.
K872928	LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH	Jan 06, 1988	Substantially Equivalent	Fidelity Medical, Inc.
K865010	MICOR	Jul 06, 1987	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K871436	PREDICTOR	Jun 19, 1987	Substantially Equivalent	Corazonix Corp.
K865035	RECORD KEEPING/DATA MANAGEMENT SYSTEM	May 11, 1987	Substantially Equivalent	Critical Care Systems, Inc.
K864583	CARDIAC PERFORMANCE MONITOR	May 11, 1987	Substantially Equivalent	Vascular Technology Incorporated
K860854	CRITICALC	Dec 08, 1986	Substantially Equivalent	Cygnus of South Florida, Inc.
K862740	QUINTON Q.CATH	Oct 31, 1986	Substantially Equivalent	Quinton, Inc.
K855055	PDS 9000 PATIENT DATA MGMT. SYSTEM	Feb 12, 1986	Substantially Equivalent	Marquette Electronics, Inc.
K851637	SIRECUST 425, RESPECTIVELY SIRECUST 430	Jul 12, 1985	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K850627	SPACELABS-GENERAL SYSTEM LINK	May 28, 1985	Substantially Equivalent	Spacelabs, Inc.
K842339	COMPUSTRESS STRESS TESTING SYS	Dec 19, 1984	Substantially Equivalent	Intl. Medical, Inc.
K840875	MULTIVARIATE DIGITAL CARDIOGRAPH	Jul 06, 1984	Substantially Equivalent	Clinical Microsystems Intl.
K834567	Q3000	Apr 30, 1984	Substantially Equivalent	Quinton, Inc.
K812739	VITALOG PMS-8 MONITOR	Dec 29, 1981	Substantially Equivalent	Vitalog Corp.
K812354	KONTRON PMS 7000	Sep 25, 1981	Substantially Equivalent	Kontron Instruments, Inc.
K810750	PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE	Mar 27, 1981	Substantially Equivalent	General Electric Co.
K810731	MODEL IM1000 INTEGRATED MONITOR	Mar 27, 1981	Substantially Equivalent	Gould, Inc.
K801810	PACEMAKER PATIENT MGMT. SYSTEM	Feb 05, 1981	Substantially Equivalent	Siemens Elema AB
K800766	ECHO-COMP	Apr 24, 1980	Substantially Equivalent	Digisonics, Inc.
K800092	COMBISON COMPUTER	Apr 08, 1980	Substantially Equivalent	Kt Medical, Inc.
K792135	DYE CURVE EVALUATOR	Jan 11, 1980	Substantially Equivalent	Sci-Pro, Inc.
K792677	DATABASE MANAGEMENT & REPORTING SYSTEM	Jan 04, 1980	Substantially Equivalent	Honeywell, Inc.
K792525	IREX CARDIOPLAN	Dec 27, 1979	Substantially Equivalent	Irex Corp.
K791776	ARRHYTHMIA II EDITOR	Oct 02, 1979	Substantially Equivalent	Spacelabs, Inc.
K782072	QUINTON STATUS 1000	Feb 23, 1979	Substantially Equivalent	Quinton, Inc.
K780468	CLINICAL GRAPHICS ANALYZER	Jun 19, 1978	Substantially Equivalent	Numonics Corp.
K780768	MODEL 5621A INTERFACE	May 26, 1978	Substantially Equivalent	Hewlett-Packard Co.
K780530	AUTOMATED PHYSIOLOGIC PROFILER	Apr 28, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K770705	CARDIAC ACQUISITION SYSTEM, ICR 2001	Jun 02, 1977	Substantially Equivalent	Instruments For Cardiac Research
K760767	MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM	Oct 13, 1976	Substantially Equivalent	Honeywell, Inc.