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
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
K043528 MIR MEDICAL INTL. RESEARCH SRL SPIROTEL 07/19/2005
K130784 MIR MEDICAL INTL. RESEARCH SRL SPIROTEL 10/30/2013
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
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
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
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
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
K052176 ZAN MESSGERATE GMBH FLOWHANDY ZAN100 USB 01/12/2006


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