Product Code: BZG FDA class 2 21 CFR 868.1840

Spirometer, Diagnostic

Anesthesiology

The Spirometer, Diagnostic is a device used to measure lung volumes and airflow rates during forced or quiet breathing maneuvers, providing data for the diagnosis and monitoring of pulmonary conditions such as asthma, chronic obstructive pulmonary disease, and restrictive lung disease. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZG, regulated under 21 CFR 868.1840 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

227

FEI Numbers

Registration Numbers

Unique Applicants

134

Years Active

Basic Information

Product Code: BZG
Device Class: FDA class 2
Regulation Number: 868.1840
Medical Specialty: Anesthesiology
Review Panel: AN
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 227 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K241843	TD-7301 Spirometer (TD-7301)	Nov 20, 2024	Substantially Equivalent	Gostar Co., Ltd
K231416	Air Next (NVD-02)	Jan 18, 2024	Substantially Equivalent	NuvoAir AB
K230501	Spirobank Oxi	Dec 15, 2023	Substantially Equivalent	MIR Medical International Research USA
K230178	EasyOne Sky Spirometer	Oct 19, 2023	Substantially Equivalent	NDD Medizintechnik AG
K222525	Alveoair Digital Spirometer	Aug 28, 2023	Substantially Equivalent	Roundworks Technologies Private Limited
K222443	Air Smart Extra Spirometer	Aug 09, 2023	Substantially Equivalent	FeelLife Health Inc.
K213754	SpiroHome Personal, SpiroHome Clinic	Jun 12, 2023	Substantially Equivalent	Inofab Saglik Teknolojileri A.S
K213872	ComPAS2	Jul 15, 2022	Substantially Equivalent	Morgan Scientific, Inc.
K212938	Vitalograph Model 6000 Alpha	Jan 26, 2022	Substantially Equivalent	Vitalograph Ireland Ltd.
K201493	Spirometer	Jun 10, 2021	Substantially Equivalent	MeHow Innovative Ltd
K202837	GoSpiro	Dec 04, 2020	Substantially Equivalent	Monitored Therapeutics, Inc.
K201562	Spirotrac	Oct 14, 2020	Substantially Equivalent	Vitalograph Ireland Ltd.
K201002	Safey Pocket Spirometer	Jul 30, 2020	Substantially Equivalent	Safey Medical Devices Pvt Ltd
K200550	Vitalograph Model 2120 In2itive eDiary	Jul 27, 2020	Substantially Equivalent	Vitalograph Ireland Ltd.
K183089	Air Next	Jan 02, 2020	Substantially Equivalent	NuvoAir AB
K183479	Asthma Monitor AM3	Oct 03, 2019	Substantially Equivalent	eResearchTechnology
K191013	Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option	Sep 10, 2019	Substantially Equivalent	Welch Allyn, Inc.
K190568	ComPAS2 (Computerized Pulmonary Analysis System)	Jun 06, 2019	Substantially Equivalent	Morgan Scientific, Inc.
K180011	Pulmonx Chartis Tablet Console	Jul 13, 2018	Substantially Equivalent	Pulmonx Corporation
K163249	GoSpiro	Mar 24, 2017	Substantially Equivalent	MONITORED THERAPEUTICS, INC.
K161536	EasyOne Air Spirometer	Jan 05, 2017	Substantially Equivalent	NDD MEDIZINTECHNIK AG
K161676	Q13 SPIROLYSER®	Oct 20, 2016	Substantially Equivalent	FIM MEDICAL
K160116	SpiroScout	Oct 07, 2016	Substantially Equivalent	GANSHORN MEDIZIN ELECTRONIC GMBH
K160253	Vitalograph Model 6300 micro	Aug 26, 2016	Substantially Equivalent	VITALOGRAPH (IRELAND) LTD.
K150515	IQSense Flow Sensor Mouthpiece	Jan 12, 2016	Substantially Equivalent	SDI DIAGNOSTICS, INC.
K142642	Vitalograph Model 6600 Compact	Jun 30, 2015	Substantially Equivalent	VITALOGRAPH(IRELAND) LTD.
K142812	Vitalograph Model 6800 Pneumotrac	Jun 29, 2015	Substantially Equivalent	VITALOGRAPH(IRELAND) LTD.
K120577	MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX	Jun 24, 2015	Substantially Equivalent	MEDIKRO OY
K150137	SpiroThor	May 27, 2015	Substantially Equivalent	Cohero Health LLC
K141793	PULMONE MINIBOXPFT 2.0	Mar 06, 2015	Substantially Equivalent	PULMONE ADVANCED MEDICAL DEVICES, LTD.
K141936	MICROBLAB, MICROLOOP	Dec 29, 2014	Substantially Equivalent	CAREFUSION GERMANY 234 GMBH
K142303	NeumoFilt Ergo/Neumo Filt BiteOn	Nov 20, 2014	Substantially Equivalent	Medical Respiratory Devices S.L.
K141546	VITALOGRAPH MODEL 7000 SPIROTRAC	Sep 03, 2014	Substantially Equivalent	VITALOGRAPH(IRELAND) LTD.
K133428	MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO	May 21, 2014	Substantially Equivalent	MEDIKRO OY
K133722	ASTHMA MONITOR AM3	May 08, 2014	Substantially Equivalent	ERESEARCH TECHNOLOGY
K130322	SPM-300	Nov 15, 2013	Substantially Equivalent	BIONET CO., LTD.
K130784	SPIROTEL	Oct 30, 2013	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K123896	CCS-200 SPIROMETER	Sep 10, 2013	Substantially Equivalent	BENSON MEDICAL INSTRUMENTS CO.
K122384	MINISPIR	Oct 04, 2012	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K120880	ORBIT	Apr 19, 2012	Substantially Equivalent	NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC
K113096	MICRO I	Apr 13, 2012	Substantially Equivalent	CAREFUSION GERMANY 234 GMBH
K103530	SPIRODOC	Nov 21, 2011	Substantially Equivalent	MEDICAL INTERNATIONAL RESEARCH USA, INC.
K111764	CHARTIS CONSOLE	Nov 10, 2011	Substantially Equivalent	PULMONX, INC.
K103575	SPIRO PD	Nov 09, 2011	Substantially Equivalent	PMD HEALTHCARE
K111587	ALERKAN SPIROMETRY FILTER	Oct 20, 2011	Substantially Equivalent	ALERKAN LTD
K100928	MICRO DIARY SPIROMETER	Mar 07, 2011	Substantially Equivalent	VIASYS RESPIRATORY CARE INC.
K101873	MASTERSCREEN IOS	Feb 10, 2011	Substantially Equivalent	CAREFUSION GERMANY 234 GMBH
K100687	VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120	Oct 16, 2010	Substantially Equivalent	VITALOGRAPH(IRELAND) LTD.
K092813	ASTRASONIC SPIROMETER, MODEL 29-8000	Jul 16, 2010	Substantially Equivalent	SDI DIAGNOSTICS, INC.
K093174	SPIROPALM	Feb 26, 2010	Substantially Equivalent	COSMED S.R.L.
K092890	ASTHMA MONITOR AM3	Jan 13, 2010	Substantially Equivalent	CAREFUSION GERMANY 234 GMBH
K090646	CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105	Jul 23, 2009	Substantially Equivalent	CHEST M.I., INC.
K083199	CHARTIS CONSOLE	Jun 25, 2009	Substantially Equivalent	PULMONX, INC.
K090034	EASY ON-PC SPIROMETER	Jun 02, 2009	Substantially Equivalent	NDD MEDIZITECHNIK AG
K090486	ASTHMA MONITOR MODEL, AM1	May 06, 2009	Substantially Equivalent	CARDINAL HEALTH GERMANY 234 GMBH
K082478	WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62	Mar 09, 2009	Substantially Equivalent	WELCH ALLYN, INC.
K083233	THE PFT FILTER	Mar 02, 2009	Substantially Equivalent	PULMONARY FILTRATION TECHNOLOGIES LLC
K083879	INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)	Feb 23, 2009	Substantially Equivalent	INNOVISION A/S
K080921	SPIRO-MASTER PC-10 SPIROMETRY SYSTEM	Jan 21, 2009	Substantially Equivalent	CHEST M.I., INC.
K082766	MODIFICATION TO MINISPIR, SPIROLAB III	Dec 17, 2008	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K073155	VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)	Jun 04, 2008	Substantially Equivalent	VITALOGRAPH(IRELAND) LTD.
K072722	MEDDORNA WIRELESS PRN SPIROMETER 100	Apr 24, 2008	Substantially Equivalent	MEDDORNA LLC
K072979	SPIROBANK G	Dec 26, 2007	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K061571	ASTRA 300	Jan 31, 2007	Substantially Equivalent	SDI DIAGNOSTICS, INC.
K062913	ASTRAGUARD PULMONARY FUNCTION FILTER	Jan 26, 2007	Substantially Equivalent	SDI DIAGNOSTICS, INC.
K061283	PULMOLIFE	Dec 14, 2006	Substantially Equivalent	MICRO MEDICAL, LTD.
K061875	MINISPIR; SPIROLAB III	Dec 11, 2006	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K061712	SPIROBANK II	Dec 01, 2006	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K052140	SPIROLAB, SPIROLAB II	Mar 16, 2006	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K052176	FLOWHANDY ZAN100 USB	Jan 12, 2006	Substantially Equivalent	ZAN MESSGERATE GMBH
K051572	KOKO LEGEND	Nov 17, 2005	Substantially Equivalent	PULMONARY DATA SERVICES, INC.
K052158	WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE	Sep 08, 2005	Substantially Equivalent	WELCH ALLYN, INC.
K051712	MODEL 2800 PFT FILTER	Sep 01, 2005	Substantially Equivalent	AIR SAFETY LTD
K042758	POLYTECH PULMONARY FUNCTION FILTER	Aug 29, 2005	Substantially Equivalent	POLYTECHNIC RESOURCES, INC.
K043528	SPIROTEL	Jul 19, 2005	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K050424	ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50	Jun 23, 2005	Substantially Equivalent	FIM MEDICAL
K042595	SPIRO'AIR	May 04, 2005	Substantially Equivalent	MORGAN SCIENTIFIC, INC.
K042058	ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN	Mar 23, 2005	Substantially Equivalent	CLEMENT CLARKE INTL., LTD.
K033518	LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103	Mar 10, 2004	Substantially Equivalent	CUSTOM PLASTIC PRODUCTS
K033939	FLOSENSE II, MODEL 29-8040	Jan 30, 2004	Substantially Equivalent	SDI DIAGNOSTICS, INC.
K031643	SPIROTEL, MODEL 29-1020	Dec 09, 2003	Substantially Equivalent	SDI DIAGNOSTICS, INC.
K031102	MICROLAB SPIROMETER	Dec 01, 2003	Substantially Equivalent	MICRO DIRECT, INC.
K030917	GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130	May 14, 2003	Substantially Equivalent	COLLINS MEDICAL, INC.
K020102	IQTEQ SPIROMETER	Mar 21, 2003	Substantially Equivalent	IQTEQ DEVELOPMENT
K030464	GEM, MODEL 004110	Mar 14, 2003	Substantially Equivalent	COLLINS MEDICAL, INC.
K023225	PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE	Dec 18, 2002	Substantially Equivalent	PURITAN BENNETT CORP.
K021200	COMPAS	Oct 18, 2002	Substantially Equivalent	MORGAN SCIENTIFIC, INC.
K022276	KOKOMATE	Oct 04, 2002	Substantially Equivalent	FERRARIS RESPIRATORY, INC.
K022103	PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM	Sep 27, 2002	Substantially Equivalent	PURITAN BENNETT CORP.
K020280	PULMOLAB EX671 EXERCISE TESTING SYSTEM	Sep 24, 2002	Substantially Equivalent	MORGAN MEDICAL LTD.
K020004	CLINDATALINK VERSION 1.0 FOR SPIROMETRY	Jul 24, 2002	Substantially Equivalent	COMPLEWARE CORP.
K013123	EMS PULMONARY FUNCTION TESTING FILTER	Mar 14, 2002	Substantially Equivalent	ENGINEERED MEDICAL SYSTEMS
K010761	SPL-50 SPIROLYSER	Mar 05, 2002	Substantially Equivalent	FIM MEDICAL
K013812	SPIROLAB II, MODEL 29	Feb 11, 2002	Substantially Equivalent	SDI DIAGNOSTICS, INC.
K013752	COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)	Jan 30, 2002	Substantially Equivalent	MORGAN SCIENTIFIC, INC.
K011470	SDI SB OFFICE, MODEL 29-	Oct 12, 2001	Substantially Equivalent	SDI DIAGNOSTICS, INC.
K001528	PC FLOW +	Jan 18, 2001	Substantially Equivalent	SPIROMETRICS MEDICAL EQUIPMENT CO.
K001278	SENSAIRE DIAGNOSTIC SPIROMETER	Nov 29, 2000	Substantially Equivalent	QRS DIAGNOSTIC, LLC.
K002499	BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE	Nov 08, 2000	Substantially Equivalent	BRENTWOOD MEDICAL TECHNOLOGY CORP.
K000599	VITALOGRAPH BASE STATION	Sep 08, 2000	Substantially Equivalent	VITALOGRAPH, INC.
K993921	NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001	May 23, 2000	Substantially Equivalent	NDD MEDICAL TECHNOLOGIES
K992823	SPIROVIT SP-2, PNEUMOCHECK II	May 12, 2000	Substantially Equivalent	SCHILLER AG
K992743	COLLINS CPL	Sep 13, 1999	Substantially Equivalent	COLLINS MEDICAL, INC.
K984031	SPIROVIT, MODEL SP-250	Apr 30, 1999	Substantially Equivalent	SCHILLER AG
K983909	MIR SPIROBANK SPIROMETER	Dec 21, 1998	Substantially Equivalent	MIR MEDICAL INTL. RESEARCH SRL
K971336	CAIRD TECHNOLOGY SPIROMETER	Dec 01, 1998	Substantially Equivalent	CAIRD TECHNOLOGY
K982956	FLOWMATE II PLUS, MODEL #4000	Nov 24, 1998	Substantially Equivalent	SPIROMETRICS MEDICAL EQUIPMENT CO.
K973138	SPIROCARD	Oct 28, 1998	Substantially Equivalent	QRS DIAGNOSTIC, LLC.
K980876	ASTHMA MONITOR AM2	Aug 14, 1998	Substantially Equivalent	ERICH JAEGER GMBH & CO. KG
K973456	SPIROBANK PORTABLE PC BASED SPIROMETER	Jul 22, 1998	Substantially Equivalent	FUTUREMED AMERICA, INC.
K980441	SPIROMETER MODEL NPB-500	Apr 30, 1998	Substantially Equivalent	NELLCOR PURITAN BENNETT, INC.
K965042	MICRODL DIARYCARD SPIROMETER	Jun 17, 1997	Substantially Equivalent	MICRO DIRECT, INC.
K963131	GRASEBY ANDERSEN'S, INTEGRITY S700	Feb 14, 1997	Substantially Equivalent	GRASEBY ANDERSEN
K963035	MICRO SPIROMETER	Nov 01, 1996	Substantially Equivalent	MICRO DIRECT, INC.
K960078	ASTHMA MONITOR	Sep 20, 1996	Substantially Equivalent	ERICH JAEGER, INC.
K953948	SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO	Jun 25, 1996	Substantially Equivalent	FUTUREMED AMERICA, INC.
K954759	FLOWMATE LTE	Apr 12, 1996	Substantially Equivalent	SPIROMETRICS MEDICAL EQUIPMENT CO.
K951718	HM-SPIRO	Dec 20, 1995	Substantially Equivalent	HILL-MED, INC.
K954140	MASTERSCREEN IOS	Dec 14, 1995	Substantially Equivalent	ERICH JAEGER GMBH & CO. KG
K950223	DISCOVERY GRAPHIC PORTABLE SPIROMETER	Nov 17, 1995	Substantially Equivalent	FUTUREMED AMERICA, INC.
K951227	DX1	Aug 11, 1995	Substantially Equivalent	CREATIVE BIOMEDICS, INC.
K946075	VITALOGRAPH MODEL 2120	Aug 04, 1995	Substantially Equivalent	VITALOGRAPH, INC.
K946322	POLYGRAM SOFTWARE	Jul 07, 1995	Substantially Equivalent	SYNECTICS MEDICAL, INC.
K951367	PORTA-SCREEN SPIROMETER	Apr 14, 1995	Substantially Equivalent	S & M INSTRUMENT CO.
K943546	FUKUDA SANGYO MODEL SPIROANALYZER ST-180	Feb 23, 1995	Substantially Equivalent	SPIROSOFT NORTHAMERICA, INC.
K944762	PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE	Dec 13, 1994	Substantially Equivalent	PURITAN BENNETT CORP.
K944175	ADAM SHELL THERMOCOUPLE ASSEMBLY	Oct 14, 1994	Substantially Equivalent	PRO-TECH SERVICES, INC.
K942779	DISPOSABLE BACTERIOLOGICAL FILTER	Jul 13, 1994	Substantially Equivalent	VITALOGRAPH, INC.
K932936	L.A.P. II SPRIOMETRY SYSTEM	Feb 10, 1994	Substantially Equivalent	ALLIED HEALTHCARE PRODUCTS, INC.
K925459	GS-MODULAR (GOLD STANDARD - MODULAR)	Feb 04, 1994	Substantially Equivalent	WARREN E. COLLINS, INC.
K923988	SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS	Oct 21, 1993	Substantially Equivalent	SENSORMEDICS CORP.
K925085	ESCORT SPIROMETER	Aug 12, 1993	Substantially Equivalent	VITALOGRAPH LTD.
K923989	SENSORMEDICS MODEL 6200 AUTOBOX DL	Aug 09, 1993	Substantially Equivalent	SENSORMEDICS CORP.
K924413	FLOWSCAN	May 06, 1993	Substantially Equivalent	ELECTROCAINE MEDICAL SYSTEM
K921513	SPIROLITE MODEL MSC-201 SPIROMETER	Jan 27, 1993	Substantially Equivalent	MEDICAL SYSTEMS CORP.
K922428	FUKUDA DENSHI MODEL SPIROSIFT SP-5000	Jan 15, 1993	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K920877	THE KEYSTONE SYSTEM	Dec 23, 1992	Substantially Equivalent	S & M INSTRUMENT CO.
K920111	SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM	Oct 26, 1992	Substantially Equivalent	SENSORMEDICS CORP.
K915451	MULTISPIRO-SX	Jul 02, 1992	Substantially Equivalent	MULTISPIRO, INC.
K914272	KOKO SPIROMETER	Jul 02, 1992	Substantially Equivalent	FERRARIS RESPIRATORY, INC.
K913396	CANNULA STYLE THERMOCOUPLES	May 22, 1992	Substantially Equivalent	PRO-TECH, INC.
K913395	EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS	May 20, 1992	Substantially Equivalent	PRO-TECH, INC.
K914205	PFF-1	May 01, 1992	Substantially Equivalent	CYBERMEDIC, INC.
K920246	SENSORMEDICS MODEL 922 SPIROMETER	Apr 08, 1992	Substantially Equivalent	SENSORMEDICS CORP.
K914219	AIRWAY THERMISTOR	Feb 26, 1992	Substantially Equivalent	SYNECTICS-DANTEC
K914085	HMS-5000	Nov 19, 1991	Substantially Equivalent	VITALOG MONITORING,INC.
K912412	VITALOGRAPH SPIROTRAC III	Oct 15, 1991	Substantially Equivalent	VITALOGRAPH LTD.
K904625	SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM	Aug 20, 1991	Substantially Equivalent	SYNECTICS-DANTEC
K910950	HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED	Aug 02, 1991	Substantially Equivalent	VITALOG MONITORING,INC.
K912234	SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION	Jul 22, 1991	Substantially Equivalent	SOMNITEC, INC.
K904200	SPIROSIFT 500A	May 22, 1991	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K910452	RESPI-PAK RT-PAK	Apr 16, 1991	Substantially Equivalent	CNS, INC.
K904118	SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.	Feb 25, 1991	Substantially Equivalent	DAWN MEDICAL
K904117	SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.	Feb 25, 1991	Substantially Equivalent	DAWN MEDICAL
K904947	PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE	Jan 30, 1991	Substantially Equivalent	PLANMECA USA, INC.
K900331	TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)	Sep 04, 1990	Substantially Equivalent	GHG MEDIZIN-ELEKTRONIK AG
K901308	SPIRO ANALYZER MODEL ST 250	Jul 23, 1990	Substantially Equivalent	FUTUREMED DIV. OF FUTURE IMPEX CORP.
K900391	FUKUDA DENSHI MODEL SPIROSIFT 3000	Apr 10, 1990	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K901057	SPIROMETRICS MODEL 2600 MIRO SPIROMETER	Apr 03, 1990	Substantially Equivalent	SPIROMETRICS, INC.
K900673	SERIAL FLOW	Apr 03, 1990	Substantially Equivalent	SPIROMETRICS, INC.
K896300	LDW SPIROMETRY SYSTEM	Apr 03, 1990	Substantially Equivalent	LANPHER DIAGNOSTIC WORKSTATIONS, INC.
K896924	SPIROSCAN 4000	Mar 01, 1990	Substantially Equivalent	BRENTWOOD INSTRUMENTS, INC.
K895414	MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM	Feb 12, 1990	Substantially Equivalent	INTEGRATED MEDICAL SYSTEMS, INC.
K895953	WRIGHT VENTILOMETER VM-1	Feb 02, 1990	Substantially Equivalent	CLEMENT CLARKE, INC.
K897094	MODIFIED SPIROSCAN 1000	Jan 12, 1990	Substantially Equivalent	FUKUDA DENSHI USA, INC.
K896121	SCHILLER MODEL SP-200 SPIROVIT(TM)	Jan 09, 1990	Substantially Equivalent	SCHILLER AMERICA, INC.
K896120	SCHILLER MODEL SP-100 SPIROVIT(TM)	Jan 09, 1990	Substantially Equivalent	SCHILLER AMERICA, INC.
K894556	SPIROTEQ	Jan 09, 1990	Substantially Equivalent	SYSTEM ANALYSIS CORP.
K895375	MULTISPIRO	Nov 27, 1989	Substantially Equivalent	MEDICAL EQUIPMENT DESIGNS, INC.
K895253	PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES	Nov 02, 1989	Substantially Equivalent	WELCH ALLYN, INC.
K894997	PRESTO DIAGNOSTIC SPIROMETER	Oct 30, 1989	Substantially Equivalent	TAMARAC SYSTEMS CORP.
K894680	RS232 FLOW SENSOR AND SOFTWARE PACKAGE	Oct 23, 1989	Substantially Equivalent	TAMARAC SYSTEMS CORP.
K891672	PUL-TRON 100K PROFESSIONAL SPIROMETER	Jun 16, 1989	Substantially Equivalent	ADVANCED MEDICAL SYSTEMS, INC.
K890522	PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER	Apr 21, 1989	Substantially Equivalent	PURITAN BENNETT CORP.
K881402	629V SPIROMETER, PULMONARY FUNCTION ANALYZER	Sep 26, 1988	Substantially Equivalent	AMERICAN ELECTROMEDICS CORP.
K873562	VITALOGRAPH-ALPHA	Aug 29, 1988	Substantially Equivalent	VITALOGRAPH LTD.
K873817	SPIRO ANALYZER ST-300	Dec 02, 1987	Substantially Equivalent	FUTUREMED DIV. OF FUTURE IMPEX CORP.
K863134	MULTISPIRO SA/100	Dec 15, 1986	Substantially Equivalent	BIOTRINE CORP.
K863656	SALTER VOLUCHEK 6600	Oct 06, 1986	Substantially Equivalent	SALTER LABS
K862023	SPIROMATE AS-600	Jun 17, 1986	Substantially Equivalent	RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP.
K861227	COLLINS PNEUMOTACH PFT SYSTEM	Jun 05, 1986	Substantially Equivalent	WARREN E. COLLINS, INC.
K860522	SPIROMETER, MODEL TS-1000, PART NO. SLZ7504	Mar 03, 1986	Substantially Equivalent	TELEDYNE AVIONICS DIV. OF TELEDYNE
K853409	SCREENMATE	Feb 05, 1986	Substantially Equivalent	ERICH JAEGER, INC.
K854403	MODEL 2120 SPIROSCREEN	Jan 14, 1986	Substantially Equivalent	GOULD, INC.
K854526	VITALOGRAPH COMPACT	Dec 24, 1985	Substantially Equivalent	VITALOGRAPH LTD.
K854062	PALL PULMONARY FUNCTION FILTER	Nov 07, 1985	Substantially Equivalent	PALL BIOMEDICAL PRODUCTS CO.
K852092	PB900 PB910 DIAGNOSTIC SPIROMETER	Jul 30, 1985	Substantially Equivalent	PURITAN BENNETT CORP.
K852677	MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM	Jul 19, 1985	Substantially Equivalent	ALPHA TECHNOLOGIES, INC.
K852307	PULMONARY TEST SYSTEM FUDAC-30	Jul 05, 1985	Substantially Equivalent	FUTUREMED DIV. OF FUTURE IMPEX CORP.
K852337	PNEUMOSCOPE	Jul 01, 1985	Substantially Equivalent	ERICH JAEGER, INC.
K851135	SPIRO SCAN	Jul 01, 1985	Substantially Equivalent	BRENTWOOD INSTRUMENTS, INC.
K852308	ST-460 SPIRO ANALYZER SPIROMETER	Jun 24, 1985	Substantially Equivalent	FUTUREMED DIV. OF FUTURE IMPEX CORP.
K851620	SPIROMED 2	May 10, 1985	Substantially Equivalent	DRAEGER MEDICAL, INC.
K851277	MICROSPIRO-SDS	Apr 19, 1985	Substantially Equivalent	MEDICAL EQUIPMENT DESIGNS, INC.
K843841	ERGO-OXYSCREEN	Dec 27, 1984	Substantially Equivalent	ERICH JAEGER, INC.
K844333	SPIROMETRICS 2451 & SMI I	Nov 20, 1984	Substantially Equivalent	SPIROMETRICS, INC.
K844226	B-1000	Nov 20, 1984	Substantially Equivalent	BIOTRINE CORP.
K843996	TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER	Nov 20, 1984	Substantially Equivalent	EQUILIBRATED BIO SYSTEMS, INC.
K843984	PM-80 PULMOTESTER	Oct 24, 1984	Substantially Equivalent	FUTURE IMPEX CORP.
K842536	CDX80	Aug 17, 1984	Substantially Equivalent	CDX CORP.
K842372	SPIROMATE AS-500	Jun 26, 1984	Substantially Equivalent	RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP.
K840972	SPIROTECH ST-550	Jun 26, 1984	Substantially Equivalent	SPIROTECH, INC.
K842041	PULMONARY FUNCTION SYSTEM	Jun 15, 1984	Substantially Equivalent	SENSOR MEDICS CORP.
K840929	FRC 85 SERIES SPIROMETER	May 14, 1984	Substantially Equivalent	MEDICAL EQUIPMENT DESIGNS, INC.
K840908	CHESTAC-25F SPIROMETER	May 14, 1984	Substantially Equivalent	MEDICAL EQUIPMENT DESIGNS, INC.
K832401	RESPIROMETER	Apr 30, 1984	Substantially Equivalent	KINETIX
K831803	PULMOMETER	Apr 30, 1984	Substantially Equivalent	KINETICS MEASUREMENT CORP.
K840741	PULMONARY FUNCTION TESTING STS	Mar 05, 1984	Substantially Equivalent	CIRCADIAN, INC.
K834475	RESPIRODYNE PULMONARY FUNCTION TEST	Feb 17, 1984	Substantially Equivalent	CHESEBROUGH-POND'S U.S.A. CO.
K832433	AUTOMATIC SPIROMETER ST-200	Sep 29, 1983	Substantially Equivalent	FUTURE IMPEX CORP.
K832432	SPIRO ANALYZER ST-100 AUTOMATIC SPIRO	Sep 29, 1983	Substantially Equivalent	FUTURE IMPEX CORP.
K832431	FUKUNDA SANGYA UNITS PULMOTESTER PM60	Sep 29, 1983	Substantially Equivalent	FUTURE IMPEX CORP.
K832430	FUKUNDA SANGYO UNITS ELECTRONIC SPIRO	Sep 29, 1983	Substantially Equivalent	FUTURE IMPEX CORP.
K832185	OHIO MODEL 922 SPIROMETER	Aug 12, 1983	Substantially Equivalent	AIRCO/OHIO MEDICAL PRODUCTS
K831497	SPIROMETRICS BREON 2400 & SMI 2400	Jun 24, 1983	Substantially Equivalent	SPIROMETRICS, INC.
K823770	SPIROTECH ST-5500	Jun 03, 1983	Substantially Equivalent	SPIROTECH, INC.
K822861	LIFELINE 4800-C DIGITAL SPIROMETER	Nov 03, 1982	Substantially Equivalent	LIFELINE CONTROLS
K820599	AUTOSPIROMETER HI-498	Apr 15, 1982	Substantially Equivalent	MEDICAL EQUIPMENT DESIGNS, INC.
K820032	VIT-O-METER	Feb 10, 1982	Substantially Equivalent	HEALTH SCAN, INC.
K820036	CXD 400	Jan 22, 1982	Substantially Equivalent	CDX CORP.
K812039	SPIROMETER 210/211	Sep 25, 1981	Substantially Equivalent	MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
K810437	BREATH METER	May 01, 1981	Substantially Equivalent	FRED SAMMONS, INC.
K791422	MINISPIROMETER SP-1	Nov 05, 1979	Substantially Equivalent	RENESCO INTERNATIONAL, INC.
K791177	DISPIRO	Aug 10, 1979	Substantially Equivalent	UTAH MEDICAL PRODUCTS, INC.
K780894	AIRFLOMETER	Dec 14, 1978	Substantially Equivalent	GLAXO AUSTRALIA PLY. LTD.
K770928	PART NO. 66-00121	May 26, 1977	Substantially Equivalent	HARLAKE CYPRANE
K770927	PART NO. 66-00311	May 26, 1977	Substantially Equivalent	HARLAKE CYPRANE

FEI Numbers

This FDA classification entry is associated with 97 FEI numbers. Click on an entry to view related FDA registrations.

1000268645: 18 registrations

1000271197: 56 registrations

1000334329: 4 registrations

1000604079: 37 registrations

1220253: 6 registrations

1316463: 77 registrations

1718873: 48 registrations

1832562: 23 registrations

2022648: 34 registrations

2024500: 35 registrations

2113281: 31 registrations

2433214: 10 registrations

2434982: 16 registrations

2518422: 147 registrations

2995: 12 registrations

3000126629: 658 registrations

3000203066: 50 registrations

3002504821: 9 registrations

3002673652: 10 registrations

3002807267: 28 registrations

3002807391: 147 registrations

3002807850: 20 registrations

3002808182: 20 registrations

3002808458: 23 registrations

3003318787: 1 registration

3003630525: 3 registrations

3003681187: 15 registrations

3004035727: 27 registrations

3004050971: 33 registrations

3004428458: 13 registrations

3004612204: 9 registrations

3005053770: 4 registrations

3005596530: 50 registrations

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3007113169: 4 registrations

3007128724: 3 registrations

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3008317830: 6 registrations

3008412416: 18 registrations

3008505660: 24 registrations

3008717264: 40 registrations

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3009327445: 14 registrations

3009443693: 11 registrations

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3010082909: 44 registrations

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3010381606: 44 registrations

3010594620: 4 registrations

3010838917: 39 registrations

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3013896610: 16 registrations

3014128536: 1 registration

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3014916466: 6 registrations

3015134004: 11 registrations

3015168843: 14 registrations

3016595211: 1 registration

3016746288: 3 registrations

3018116884: 33 registrations

3018188848: 3 registrations

3018783526: 184 registrations

3023272766: 173 registrations

3024023244: 5 registrations

3025604886: 16 registrations

3026576087: 14 registrations

3027510187: 1 registration

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3030447506: 78 registrations

3032059850: 2 registrations

3033536319: 44 registrations

3033959233: 56 registrations

3036774597: 1 registration

3038190107: 1 registration