FDA 510(k) Applications for Medical Device Product Code "BZG"
(Spirometer, Diagnostic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K051712 | AIR SAFETY LTD | MODEL 2800 PFT FILTER | 09/01/2005 |
| K111587 | ALERKAN LTD | ALERKAN SPIROMETRY FILTER | 10/20/2011 |
| K123896 | BENSON MEDICAL INSTRUMENTS CO. | CCS-200 SPIROMETER | 09/10/2013 |
| K130322 | BIONET CO., LTD. | SPM-300 | 11/15/2013 |
| 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 |
| 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 |
| K042058 | CLEMENT CLARKE INTL., LTD. | ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN | 03/23/2005 |
| 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 |
| K033518 | CUSTOM PLASTIC PRODUCTS | LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 | 03/10/2004 |
| K013123 | ENGINEERED MEDICAL SYSTEMS | EMS PULMONARY FUNCTION TESTING FILTER | 03/14/2002 |
| 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 |
| K960078 | ERICH JAEGER, INC. | ASTHMA MONITOR | 09/20/1996 |
| K222443 | FeelLife Health Inc. | Air Smart Extra Spirometer | 08/09/2023 |
| 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 |
| 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 |
| K160116 | GANSHORN MEDIZIN ELECTRONIC GMBH | SpiroScout | 10/07/2016 |
| K963131 | GRASEBY ANDERSEN | GRASEBY ANDERSEN'S, INTEGRITY S700 | 02/14/1997 |
| K083879 | INNOVISION A/S | INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) | 02/23/2009 |
| K213754 | Inofab Saglik Teknolojileri A.S | SpiroHome Personal, SpiroHome Clinic | 06/12/2023 |
| K020102 | IQTEQ DEVELOPMENT | IQTEQ SPIROMETER | 03/21/2003 |
| K072722 | MEDDORNA LLC | MEDDORNA WIRELESS PRN SPIROMETER 100 | 04/24/2008 |
| K103530 | MEDICAL INTERNATIONAL RESEARCH USA, INC. | SPIRODOC | 11/21/2011 |
| K142303 | Medical Respiratory Devices S.L. | NeumoFilt Ergo/Neumo Filt BiteOn | 11/20/2014 |
| 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 |
| K201493 | MeHow Innovative Ltd | Spirometer | 06/10/2021 |
| 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 |
| K202837 | Monitored Therapeutics, Inc. | GoSpiro | 12/04/2020 |
| 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 |
| K213872 | Morgan Scientific, Inc. | ComPAS2 | 07/15/2022 |
| K190568 | Morgan Scientific, Inc. | ComPAS2 (Computerized Pulmonary Analysis System) | 06/06/2019 |
| K042595 | MORGAN SCIENTIFIC, INC. | SPIRO'AIR | 05/04/2005 |
| 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 |
| K103575 | PMD HEALTHCARE | SPIRO PD | 11/09/2011 |
| K042758 | POLYTECHNIC RESOURCES, INC. | POLYTECH PULMONARY FUNCTION FILTER | 08/29/2005 |
| 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 |
| K023225 | PURITAN BENNETT CORP. | PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE | 12/18/2002 |
| K022103 | PURITAN BENNETT CORP. | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM | 09/27/2002 |
| K001278 | QRS DIAGNOSTIC, LLC. | SENSAIRE DIAGNOSTIC SPIROMETER | 11/29/2000 |
| K973138 | QRS DIAGNOSTIC, LLC. | SPIROCARD | 10/28/1998 |
| K222525 | Roundworks Technologies Private Limited | Alveoair Digital Spirometer | 08/28/2023 |
| K201002 | Safey Medical Devices Pvt Ltd | Safey Pocket Spirometer | 07/30/2020 |
| K992823 | SCHILLER AG | SPIROVIT SP-2, PNEUMOCHECK II | 05/12/2000 |
| K984031 | SCHILLER AG | SPIROVIT, MODEL SP-250 | 04/30/1999 |
| 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 |
| 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 |
| K100928 | VIASYS RESPIRATORY CARE INC. | MICRO DIARY SPIROMETER | 03/07/2011 |
| K160253 | VITALOGRAPH (IRELAND) LTD. | Vitalograph Model 6300 micro | 08/26/2016 |
| K201562 | Vitalograph Ireland Ltd. | Spirotrac | 10/14/2020 |
| K200550 | Vitalograph Ireland Ltd. | Vitalograph Model 2120 In2itive eDiary | 07/27/2020 |
| K212938 | Vitalograph Ireland Ltd. | Vitalograph Model 6000 Alpha | 01/26/2022 |
| K000599 | VITALOGRAPH, INC. | VITALOGRAPH BASE STATION | 09/08/2000 |
| 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 |
| 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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