FDA 510(k) Applications for Medical Device Product Code "BZG"
(Spirometer, Diagnostic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K891672 | ADVANTAGE MEDICAL SYSTEMS, INC. | PUL-TRON 100K PROFESSIONAL SPIROMETER | 06/16/1989 |
| K051712 | AIR SAFETY LTD | MODEL 2800 PFT FILTER | 09/01/2005 |
| K832185 | AIRCO/OHIO MEDICAL PRODUCTS | OHIO MODEL 922 SPIROMETER | 08/12/1983 |
| K111587 | ALERKAN LTD | ALERKAN SPIROMETRY FILTER | 10/20/2011 |
| K932936 | ALLIED HEALTHCARE PRODUCTS, INC. | L.A.P. II SPRIOMETRY SYSTEM | 02/10/1994 |
| K852677 | ALPHA TECHNOLOGIES, INC. | MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM | 07/19/1985 |
| K881402 | AMERICAN ELECTROMEDICS CORP. | 629V SPIROMETER, PULMONARY FUNCTION ANALYZER | 09/26/1988 |
| K123896 | BENSON MEDICAL INSTRUMENTS CO. | CCS-200 SPIROMETER | 09/10/2013 |
| K130322 | BIONET CO., LTD. | SPM-300 | 11/15/2013 |
| K844226 | BIOTRINE CORP. | B-1000 | 11/20/1984 |
| K863134 | BIOTRINE CORP. | MULTISPIRO SA/100 | 12/15/1986 |
| K851135 | BRENTWOOD INSTRUMENTS, INC. | SPIRO SCAN | 07/01/1985 |
| K896924 | BRENTWOOD INSTRUMENTS, INC. | SPIROSCAN 4000 | 03/01/1990 |
| K002499 | BRENTWOOD MEDICAL TECHNOLOGY CORP. | BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE | 11/08/2000 |
| K971336 | CAIRD TECHNOLOGY | CAIRD TECHNOLOGY SPIROMETER | 12/01/1998 |
| K090486 | CARDINAL HEALTH GERMANY 234 GMBH | ASTHMA MONITOR MODEL, AM1 | 05/06/2009 |
| K092890 | CAREFUSION GERMANY 234 GMBH | ASTHMA MONITOR AM3 | 01/13/2010 |
| K101873 | CAREFUSION GERMANY 234 GMBH | MASTERSCREEN IOS | 02/10/2011 |
| K113096 | CAREFUSION GERMANY 234 GMBH | MICRO I | 04/13/2012 |
| K141936 | CAREFUSION GERMANY 234 GMBH | MICROBLAB, MICROLOOP | 12/29/2014 |
| K842536 | CDX CORP. | CDX80 | 08/17/1984 |
| K820036 | CDX CORP. | CXD 400 | 01/22/1982 |
| K834475 | CHESEBROUGH-POND'S U.S.A. CO. | RESPIRODYNE PULMONARY FUNCTION TEST | 02/17/1984 |
| K090646 | CHEST M.I., INC. | CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 | 07/23/2009 |
| K080921 | CHEST M.I., INC. | SPIRO-MASTER PC-10 SPIROMETRY SYSTEM | 01/21/2009 |
| K840741 | CIRCADIAN, INC. | PULMONARY FUNCTION TESTING STS | 03/05/1984 |
| K042058 | CLEMENT CLARKE INTL., LTD. | ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN | 03/23/2005 |
| K895953 | CLEMENT CLARKE, INC. | WRIGHT VENTILOMETER VM-1 | 02/02/1990 |
| K910452 | CNS, INC. | RESPI-PAK RT-PAK | 04/16/1991 |
| K150137 | Cohero Health LLC | SpiroThor | 05/27/2015 |
| K992743 | COLLINS MEDICAL, INC. | COLLINS CPL | 09/13/1999 |
| K030464 | COLLINS MEDICAL, INC. | GEM, MODEL 004110 | 03/14/2003 |
| K030917 | COLLINS MEDICAL, INC. | GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 | 05/14/2003 |
| K020004 | COMPLEWARE CORP. | CLINDATALINK VERSION 1.0 FOR SPIROMETRY | 07/24/2002 |
| K093174 | COSMED S.R.L. | SPIROPALM | 02/26/2010 |
| K951227 | CREATIVE BIOMEDICS, INC. | DX1 | 08/11/1995 |
| K033518 | CUSTOM PLASTIC PRODUCTS | LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 | 03/10/2004 |
| K914205 | CYBERMEDIC, INC. | PFF-1 | 05/01/1992 |
| K904117 | DAWN MEDICAL | SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. | 02/25/1991 |
| K904118 | DAWN MEDICAL | SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. | 02/25/1991 |
| K851620 | DRAEGER MEDICAL, INC. | SPIROMED 2 | 05/10/1985 |
| K924413 | ELECTROCAINE MEDICAL SYSTEM | FLOWSCAN | 05/06/1993 |
| K013123 | ENGINEERED MEDICAL SYSTEMS | EMS PULMONARY FUNCTION TESTING FILTER | 03/14/2002 |
| K843996 | EQUILIBRATED BIO SYSTEMS, INC. | TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER | 11/20/1984 |
| K133722 | ERESEARCH TECHNOLOGY | ASTHMA MONITOR AM3 | 05/08/2014 |
| K183479 | eResearchTechnology | Asthma Monitor AM3 | 10/03/2019 |
| K980876 | ERICH JAEGER GMBH & CO. KG | ASTHMA MONITOR AM2 | 08/14/1998 |
| K954140 | ERICH JAEGER GMBH & CO. KG | MASTERSCREEN IOS | 12/14/1995 |
| K960078 | ERICH JAEGER, INC. | ASTHMA MONITOR | 09/20/1996 |
| K843841 | ERICH JAEGER, INC. | ERGO-OXYSCREEN | 12/27/1984 |
| K852337 | ERICH JAEGER, INC. | PNEUMOSCOPE | 07/01/1985 |
| K853409 | ERICH JAEGER, INC. | SCREENMATE | 02/05/1986 |
| K914272 | FERRARIS RESPIRATORY, INC. | KOKO SPIROMETER | 07/02/1992 |
| K022276 | FERRARIS RESPIRATORY, INC. | KOKOMATE | 10/04/2002 |
| K050424 | FIM MEDICAL | ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 | 06/23/2005 |
| K161676 | FIM MEDICAL | Q13 SPIROLYSER« | 10/20/2016 |
| K010761 | FIM MEDICAL | SPL-50 SPIROLYSER | 03/05/2002 |
| K810437 | FRED SAMMONS, INC. | BREATH METER | 05/01/1981 |
| K900391 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI MODEL SPIROSIFT 3000 | 04/10/1990 |
| K922428 | FUKUDA DENSHI USA, INC. | FUKUDA DENSHI MODEL SPIROSIFT SP-5000 | 01/15/1993 |
| K897094 | FUKUDA DENSHI USA, INC. | MODIFIED SPIROSCAN 1000 | 01/12/1990 |
| K904200 | FUKUDA DENSHI USA, INC. | SPIROSIFT 500A | 05/22/1991 |
| K832433 | FUTURE IMPEX CORP. | AUTOMATIC SPIROMETER ST-200 | 09/29/1983 |
| K832431 | FUTURE IMPEX CORP. | FUKUNDA SANGYA UNITS PULMOTESTER PM60 | 09/29/1983 |
| K832430 | FUTURE IMPEX CORP. | FUKUNDA SANGYO UNITS ELECTRONIC SPIRO | 09/29/1983 |
| K843984 | FUTURE IMPEX CORP. | PM-80 PULMOTESTER | 10/24/1984 |
| K832432 | FUTURE IMPEX CORP. | SPIRO ANALYZER ST-100 AUTOMATIC SPIRO | 09/29/1983 |
| K950223 | FUTUREMED AMERICA, INC. | DISCOVERY GRAPHIC PORTABLE SPIROMETER | 11/17/1995 |
| K973456 | FUTUREMED AMERICA, INC. | SPIROBANK PORTABLE PC BASED SPIROMETER | 07/22/1998 |
| K953948 | FUTUREMED AMERICA, INC. | SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO | 06/25/1996 |
| K852307 | FUTUREMED DIV. OF FUTURE IMPEX CORP. | PULMONARY TEST SYSTEM FUDAC-30 | 07/05/1985 |
| K901308 | FUTUREMED DIV. OF FUTURE IMPEX CORP. | SPIRO ANALYZER MODEL ST 250 | 07/23/1990 |
| K873817 | FUTUREMED DIV. OF FUTURE IMPEX CORP. | SPIRO ANALYZER ST-300 | 12/02/1987 |
| K852308 | FUTUREMED DIV. OF FUTURE IMPEX CORP. | ST-460 SPIRO ANALYZER SPIROMETER | 06/24/1985 |
| K160116 | GANSHORN MEDIZIN ELECTRONIC GMBH | SpiroScout | 10/07/2016 |
| K900331 | GHG MEDIZIN-ELEKTRONIK AG | TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER) | 09/04/1990 |
| K780894 | GLAXO AUSTRALIA PLY. LTD. | AIRFLOMETER | 12/14/1978 |
| K854403 | GOULD, INC. | MODEL 2120 SPIROSCREEN | 01/14/1986 |
| K963131 | GRASEBY ANDERSEN | GRASEBY ANDERSEN'S, INTEGRITY S700 | 02/14/1997 |
| K770928 | HARLAKE CYPRANE | PART NO. 66-00121 | 05/26/1977 |
| K770927 | HARLAKE CYPRANE | PART NO. 66-00311 | 05/26/1977 |
| K820032 | HEALTH SCAN, INC. | VIT-O-METER | 02/10/1982 |
| K951718 | HILL-MED, INC. | HM-SPIRO | 12/20/1995 |
| K083879 | INNOVISION A/S | INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) | 02/23/2009 |
| K895414 | INTEGRATED MEDICAL SYSTEMS, INC. | MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM | 02/12/1990 |
| K020102 | IQTEQ DEVELOPMENT | IQTEQ SPIROMETER | 03/21/2003 |
| K831803 | KINETICS MEASUREMENT CORP. | PULMOMETER | 04/30/1984 |
| K832401 | KINETIX | RESPIROMETER | 04/30/1984 |
| K896300 | LANPHER DIAGNOSTIC WORKSTATIONS, INC. | LDW SPIROMETRY SYSTEM | 04/03/1990 |
| K822861 | LIFELINE CONTROLS | LIFELINE 4800-C DIGITAL SPIROMETER | 11/03/1982 |
| K072722 | MEDDORNA LLC | MEDDORNA WIRELESS PRN SPIROMETER 100 | 04/24/2008 |
| K820599 | MEDICAL EQUIPMENT DESIGNS, INC. | AUTOSPIROMETER HI-498 | 04/15/1982 |
| K840908 | MEDICAL EQUIPMENT DESIGNS, INC. | CHESTAC-25F SPIROMETER | 05/14/1984 |
| K840929 | MEDICAL EQUIPMENT DESIGNS, INC. | FRC 85 SERIES SPIROMETER | 05/14/1984 |
| K851277 | MEDICAL EQUIPMENT DESIGNS, INC. | MICROSPIRO-SDS | 04/19/1985 |
| K895375 | MEDICAL EQUIPMENT DESIGNS, INC. | MULTISPIRO | 11/27/1989 |
| K103530 | MEDICAL INTERNATIONAL RESEARCH USA, INC. | SPIRODOC | 11/21/2011 |
| K142303 | Medical Respiratory Devices S.L. | NeumoFilt Ergo/Neumo Filt BiteOn | 11/20/2014 |
| K921513 | MEDICAL SYSTEMS CORP. | SPIROLITE MODEL MSC-201 SPIROMETER | 01/27/1993 |
| K133428 | MEDIKRO OY | MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO | 05/21/2014 |
| K120577 | MEDIKRO OY | MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX | 06/24/2015 |
| K812039 | MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. | SPIROMETER 210/211 | 09/25/1981 |
| K963035 | MICRO DIRECT, INC. | MICRO SPIROMETER | 11/01/1996 |
| K965042 | MICRO DIRECT, INC. | MICRODL DIARYCARD SPIROMETER | 06/17/1997 |
| K031102 | MICRO DIRECT, INC. | MICROLAB SPIROMETER | 12/01/2003 |
| K061283 | MICRO MEDICAL, LTD. | PULMOLIFE | 12/14/2006 |
| K122384 | MIR MEDICAL INTL. RESEARCH SRL | MINISPIR | 10/04/2012 |
| K061875 | MIR MEDICAL INTL. RESEARCH SRL | MINISPIR; SPIROLAB III | 12/11/2006 |
| K983909 | MIR MEDICAL INTL. RESEARCH SRL | MIR SPIROBANK SPIROMETER | 12/21/1998 |
| K082766 | MIR MEDICAL INTL. RESEARCH SRL | MODIFICATION TO MINISPIR, SPIROLAB III | 12/17/2008 |
| K072979 | MIR MEDICAL INTL. RESEARCH SRL | SPIROBANK G | 12/26/2007 |
| K061712 | MIR MEDICAL INTL. RESEARCH SRL | SPIROBANK II | 12/01/2006 |
| K052140 | MIR MEDICAL INTL. RESEARCH SRL | SPIROLAB, SPIROLAB II | 03/16/2006 |
| K130784 | MIR MEDICAL INTL. RESEARCH SRL | SPIROTEL | 10/30/2013 |
| K043528 | MIR MEDICAL INTL. RESEARCH SRL | SPIROTEL | 07/19/2005 |
| K163249 | MONITORED THERAPEUTICS, INC. | GoSpiro | 03/24/2017 |
| K020280 | MORGAN MEDICAL LTD. | PULMOLAB EX671 EXERCISE TESTING SYSTEM | 09/24/2002 |
| K021200 | MORGAN SCIENTIFIC, INC. | COMPAS | 10/18/2002 |
| K013752 | MORGAN SCIENTIFIC, INC. | COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) | 01/30/2002 |
| K190568 | Morgan Scientific, Inc. | ComPAS2 (Computerized Pulmonary Analysis System) | 06/06/2019 |
| K042595 | MORGAN SCIENTIFIC, INC. | SPIRO'AIR | 05/04/2005 |
| K915451 | MULTISPIRO, INC. | MULTISPIRO-SX | 07/02/1992 |
| K120880 | NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC | ORBIT | 04/19/2012 |
| K993921 | NDD MEDICAL TECHNOLOGIES | NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001 | 05/23/2000 |
| K161536 | NDD MEDIZINTECHNIK AG | EasyOne Air Spirometer | 01/05/2017 |
| K090034 | NDD MEDIZITECHNIK AG | EASY ON-PC SPIROMETER | 06/02/2009 |
| K980441 | NELLCOR PURITAN BENNETT, INC. | SPIROMETER MODEL NPB-500 | 04/30/1998 |
| K183089 | NuvoAir AB | Air Next | 01/02/2020 |
| K854062 | PALL BIOMEDICAL PRODUCTS CO. | PALL PULMONARY FUNCTION FILTER | 11/07/1985 |
| K904947 | PLANMECA USA, INC. | PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE | 01/30/1991 |
| K103575 | PMD HEALTHCARE | SPIRO PD | 11/09/2011 |
| K042758 | POLYTECHNIC RESOURCES, INC. | POLYTECH PULMONARY FUNCTION FILTER | 08/29/2005 |
| K944175 | PRO-TECH SERVICES, INC. | ADAM SHELL THERMOCOUPLE ASSEMBLY | 10/14/1994 |
| K913396 | PRO-TECH, INC. | CANNULA STYLE THERMOCOUPLES | 05/22/1992 |
| K913395 | PRO-TECH, INC. | EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS | 05/20/1992 |
| K051572 | PULMONARY DATA SERVICES, INC. | KOKO LEGEND | 11/17/2005 |
| K083233 | PULMONARY FILTRATION TECHNOLOGIES LLC | THE PFT FILTER | 03/02/2009 |
| K141793 | PULMONE ADVANCED MEDICAL DEVICES, LTD. | PULMONE MINIBOXPFT 2.0 | 03/06/2015 |
| K180011 | Pulmonx Corporation | Pulmonx Chartis Tablet Console | 07/13/2018 |
| K083199 | PULMONX, INC. | CHARTIS CONSOLE | 06/25/2009 |
| K111764 | PULMONX, INC. | CHARTIS CONSOLE | 11/10/2011 |
| K852092 | PURITAN BENNETT CORP. | PB900 PB910 DIAGNOSTIC SPIROMETER | 07/30/1985 |
| K023225 | PURITAN BENNETT CORP. | PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE | 12/18/2002 |
| K890522 | PURITAN BENNETT CORP. | PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER | 04/21/1989 |
| K022103 | PURITAN BENNETT CORP. | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM | 09/27/2002 |
| K944762 | PURITAN BENNETT CORP. | PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE | 12/13/1994 |
| K001278 | QRS DIAGNOSTIC, LLC. | SENSAIRE DIAGNOSTIC SPIROMETER | 11/29/2000 |
| K973138 | QRS DIAGNOSTIC, LLC. | SPIROCARD | 10/28/1998 |
| K791422 | RENESCO INTERNATIONAL, INC. | MINISPIROMETER SP-1 | 11/05/1979 |
| K842372 | RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP. | SPIROMATE AS-500 | 06/26/1984 |
| K862023 | RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP. | SPIROMATE AS-600 | 06/17/1986 |
| K951367 | S & M INSTRUMENT CO. | PORTA-SCREEN SPIROMETER | 04/14/1995 |
| K920877 | S & M INSTRUMENT CO. | THE KEYSTONE SYSTEM | 12/23/1992 |
| K201002 | Safey Medical Devices Pvt Ltd | Safey Pocket Spirometer | 07/30/2020 |
| K863656 | SALTER LABS | SALTER VOLUCHEK 6600 | 10/06/1986 |
| K992823 | SCHILLER AG | SPIROVIT SP-2, PNEUMOCHECK II | 05/12/2000 |
| K984031 | SCHILLER AG | SPIROVIT, MODEL SP-250 | 04/30/1999 |
| K896120 | SCHILLER AMERICA, INC. | SCHILLER MODEL SP-100 SPIROVIT(TM) | 01/09/1990 |
| K896121 | SCHILLER AMERICA, INC. | SCHILLER MODEL SP-200 SPIROVIT(TM) | 01/09/1990 |
| K061571 | SDI DIAGNOSTICS, INC. | ASTRA 300 | 01/31/2007 |
| K062913 | SDI DIAGNOSTICS, INC. | ASTRAGUARD PULMONARY FUNCTION FILTER | 01/26/2007 |
| K092813 | SDI DIAGNOSTICS, INC. | ASTRASONIC SPIROMETER, MODEL 29-8000 | 07/16/2010 |
| K033939 | SDI DIAGNOSTICS, INC. | FLOSENSE II, MODEL 29-8040 | 01/30/2004 |
| K150515 | SDI DIAGNOSTICS, INC. | IQSense Flow Sensor Mouthpiece | 01/12/2016 |
| K011470 | SDI DIAGNOSTICS, INC. | SDI SB OFFICE, MODEL 29- | 10/12/2001 |
| K013812 | SDI DIAGNOSTICS, INC. | SPIROLAB II, MODEL 29 | 02/11/2002 |
| K031643 | SDI DIAGNOSTICS, INC. | SPIROTEL, MODEL 29-1020 | 12/09/2003 |
| K842041 | SENSOR MEDICS CORP. | PULMONARY FUNCTION SYSTEM | 06/15/1984 |
| K920111 | SENSORMEDICS CORP. | SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM | 10/26/1992 |
| K923988 | SENSORMEDICS CORP. | SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS | 10/21/1993 |
| K923989 | SENSORMEDICS CORP. | SENSORMEDICS MODEL 6200 AUTOBOX DL | 08/09/1993 |
| K920246 | SENSORMEDICS CORP. | SENSORMEDICS MODEL 922 SPIROMETER | 04/08/1992 |
| K912234 | SOMNITEC, INC. | SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION | 07/22/1991 |
| K982956 | SPIROMETRICS MEDICAL EQUIPMENT CO. | FLOWMATE II PLUS, MODEL #4000 | 11/24/1998 |
| K954759 | SPIROMETRICS MEDICAL EQUIPMENT CO. | FLOWMATE LTE | 04/12/1996 |
| K001528 | SPIROMETRICS MEDICAL EQUIPMENT CO. | PC FLOW + | 01/18/2001 |
| K900673 | SPIROMETRICS, INC. | SERIAL FLOW | 04/03/1990 |
| K844333 | SPIROMETRICS, INC. | SPIROMETRICS 2451 & SMI I | 11/20/1984 |
| K831497 | SPIROMETRICS, INC. | SPIROMETRICS BREON 2400 & SMI 2400 | 06/24/1983 |
| K901057 | SPIROMETRICS, INC. | SPIROMETRICS MODEL 2600 MIRO SPIROMETER | 04/03/1990 |
| K943546 | SPIROSOFT NORTHAMERICA, INC. | FUKUDA SANGYO MODEL SPIROANALYZER ST-180 | 02/23/1995 |
| K840972 | SPIROTECH, INC. | SPIROTECH ST-550 | 06/26/1984 |
| K823770 | SPIROTECH, INC. | SPIROTECH ST-5500 | 06/03/1983 |
| K946322 | SYNECTICS MEDICAL, INC. | POLYGRAM SOFTWARE | 07/07/1995 |
| K914219 | SYNECTICS-DANTEC | AIRWAY THERMISTOR | 02/26/1992 |
| K904625 | SYNECTICS-DANTEC | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM | 08/20/1991 |
| K894556 | SYSTEM ANALYSIS CORP. | SPIROTEQ | 01/09/1990 |
| K894997 | TAMARAC SYSTEMS CORP. | PRESTO DIAGNOSTIC SPIROMETER | 10/30/1989 |
| K894680 | TAMARAC SYSTEMS CORP. | RS232 FLOW SENSOR AND SOFTWARE PACKAGE | 10/23/1989 |
| K860522 | TELEDYNE AVIONICS DIV. OF TELEDYNE | SPIROMETER, MODEL TS-1000, PART NO. SLZ7504 | 03/03/1986 |
| K791177 | UTAH MEDICAL PRODUCTS, INC. | DISPIRO | 08/10/1979 |
| K100928 | VIASYS RESPIRATORY CARE INC. | MICRO DIARY SPIROMETER | 03/07/2011 |
| K910950 | VITALOG MONITORING,INC. | HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED | 08/02/1991 |
| K914085 | VITALOG MONITORING,INC. | HMS-5000 | 11/19/1991 |
| K160253 | VITALOGRAPH (IRELAND) LTD. | Vitalograph Model 6300 micro | 08/26/2016 |
| K200550 | Vitalograph Ireland Ltd. | Vitalograph Model 2120 In2itive eDiary | 07/27/2020 |
| K925085 | VITALOGRAPH LTD. | ESCORT SPIROMETER | 08/12/1993 |
| K854526 | VITALOGRAPH LTD. | VITALOGRAPH COMPACT | 12/24/1985 |
| K912412 | VITALOGRAPH LTD. | VITALOGRAPH SPIROTRAC III | 10/15/1991 |
| K873562 | VITALOGRAPH LTD. | VITALOGRAPH-ALPHA | 08/29/1988 |
| K100687 | VITALOGRAPH(IRELAND) LTD. | VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 | 10/16/2010 |
| K073155 | VITALOGRAPH(IRELAND) LTD. | VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) | 06/04/2008 |
| K142642 | VITALOGRAPH(IRELAND) LTD. | Vitalograph Model 6600 Compact | 06/30/2015 |
| K142812 | VITALOGRAPH(IRELAND) LTD. | Vitalograph Model 6800 Pneumotrac | 06/29/2015 |
| K141546 | VITALOGRAPH(IRELAND) LTD. | VITALOGRAPH MODEL 7000 SPIROTRAC | 09/03/2014 |
| K942779 | VITALOGRAPH, INC. | DISPOSABLE BACTERIOLOGICAL FILTER | 07/13/1994 |
| K000599 | VITALOGRAPH, INC. | VITALOGRAPH BASE STATION | 09/08/2000 |
| K946075 | VITALOGRAPH, INC. | VITALOGRAPH MODEL 2120 | 08/04/1995 |
| K861227 | WARREN E. COLLINS, INC. | COLLINS PNEUMOTACH PFT SYSTEM | 06/05/1986 |
| K925459 | WARREN E. COLLINS, INC. | GS-MODULAR (GOLD STANDARD - MODULAR) | 02/04/1994 |
| K895253 | WELCH ALLYN, INC. | PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES | 11/02/1989 |
| K082478 | WELCH ALLYN, INC. | WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 | 03/09/2009 |
| K052158 | WELCH ALLYN, INC. | WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE | 09/08/2005 |
| K191013 | Welch Allyn, Inc. | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | 09/10/2019 |
| K052176 | ZAN MESSGERATE GMBH | FLOWHANDY ZAN100 USB | 01/12/2006 |
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