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Panels › Anesthesiology › Product code BZG · Class 2

Spirometer, Diagnostic

Regulation 868.1840

1510(k)s in 12 months (228 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in BZG

Company510(k)sRecalls
Mir Medical Intl. Research Srl90
Vitalograph (Ireland) , Ltd.90
Sdi Diagnostics, Inc.80
Vitalograph , Ltd.70
Erich Jaeger GmbH & Co. KG60
Future Impex Corp.50
Medical Equipment Designs, Inc.50
Morgan Scientific, Inc.50
Puritan Bennett Corp.50
Sensor Medics Corp.50
Decided510(k)Device and applicantCode
Mar 2, 2026K251777MESI mTABLET SPIRO
Mesi D.O.O., SI
BZG
Nov 20, 2024K241843TD-7301 Spirometer (TD-7301)
Gostar Co., Ltd., TW
BZG
Jan 18, 2024K231416Air Next (NVD-02)
Nuvoair AB, SE
BZG
Dec 15, 2023K230501Spirobank Oxi
Mir Medical International Research USA
BZG
Oct 19, 2023K230178EasyOne Sky Spirometer
Ndd Medizintechnik AG, CH
BZG
Aug 28, 2023K222525Alveoair Digital Spirometer
Roundworks Technologies Private Limited, IN
BZG
Aug 9, 2023K222443Air Smart Extra Spirometer
Feellife Health, Inc., CN
BZG
Jun 12, 2023K213754SpiroHome Personal, SpiroHome Clinic
Inofab Saglik Teknolojileri A.S, TR
BZG
Jul 15, 2022K213872ComPAS2
Morgan Scientific, Inc.
BZG
Jan 26, 2022K212938Vitalograph Model 6000 Alpha
Vitalograph Ireland, Ltd., IE
BZG
Jun 10, 2021K201493Spirometer
Mehow Innovative, Ltd., CN
BZG
Dec 4, 2020K202837GoSpiro
Monitored Therapeutics, Inc.
BZG
Oct 14, 2020K201562Spirotrac
Vitalograph Ireland, Ltd., IE
BZG
Jul 30, 2020K201002Safey Pocket Spirometer
Safey Medical Devices Pvt, Ltd., IN
BZG
Jul 27, 2020K200550Vitalograph Model 2120 In2itive eDiary
Vitalograph Ireland, Ltd., IE
BZG
Jan 2, 2020K183089Air Next
Nuvoair AB, SE
BZG
Oct 3, 2019K183479Asthma Monitor AM3
Eresearch Technology, DE
BZG
Sep 10, 2019K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
Welch Allyn, Inc.
BZG
Jun 6, 2019K190568ComPAS2 (Computerized Pulmonary Analysis System)
Morgan Scientific, Inc.
BZG
Jul 13, 2018K180011Pulmonx Chartis Tablet Console
Pulmonx Corporation
BZG
Mar 24, 2017K163249GoSpiro
Monitored Therapeutics, Inc.
BZG
Jan 5, 2017K161536EasyOne Air Spirometer
Ndd Medizintechnik AG, CH
BZG
Oct 20, 2016K161676Q13 SPIROLYSER®
Fim Medical, FR
BZG
Oct 7, 2016K160116SpiroScout
Ganshorn Medizin Electronic GmbH, DE
BZG
Aug 26, 2016K160253Vitalograph Model 6300 micro
Vitalograph (Ireland) , Ltd., IE
BZG
Jan 12, 2016K150515IQSense Flow Sensor Mouthpiece
Sdi Diagnostics, Inc.
BZG
Jun 30, 2015K142642Vitalograph Model 6600 Compact
Vitalograph (Ireland) , Ltd., IE
BZG
Jun 29, 2015K142812Vitalograph Model 6800 Pneumotrac
Vitalograph (Ireland) , Ltd., IE
BZG
Jun 24, 2015K120577MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
Medikro OY, FI
BZG
May 27, 2015K150137SpiroThor
Cohero Health, LLC
BZG
Mar 6, 2015K141793PULMONE MINIBOXPFT 2.0
Pulmone Advanced Medical Devices, Ltd.
BZG
Dec 29, 2014K141936MICROBLAB, MICROLOOP
Carefusion Germany 234 GmbH, DE
BZG
Nov 20, 2014K142303NeumoFilt Ergo/Neumo Filt BiteOn
Medical Respiratory Devices S.L., ES
BZG
Sep 3, 2014K141546VITALOGRAPH MODEL 7000 SPIROTRAC
Vitalograph (Ireland) , Ltd., IE
BZG
May 21, 2014K133428MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
Medikro OY, FI
BZG
May 8, 2014K133722ASTHMA MONITOR AM3
Eresearch Technology
BZG
Nov 15, 2013K130322SPM-300
Bionet Co., Ltd.
BZG
Oct 30, 2013K130784SPIROTEL
Mir Medical Intl. Research Srl, IT
BZG
Sep 10, 2013K123896CCS-200 SPIROMETER
Benson Medical Instruments Co.
BZG
Oct 4, 2012K122384MINISPIR
Mir Medical Intl. Research Srl, IT
BZG
Apr 19, 2012K120880ORBIT
National Biomedical, LLC Dba Qrs Diagnostic
BZG
Apr 13, 2012K113096MICRO I
Carefusion Germany 234 GmbH, DE
BZG
Nov 21, 2011K103530SPIRODOC
Medical International Research USA, Inc.
BZG
Nov 10, 2011K111764CHARTIS CONSOLE
Pulmonx, Inc.
BZG
Nov 9, 2011K103575SPIRO PD
Pmd Healthcare
BZG
Oct 20, 2011K111587ALERKAN SPIROMETRY FILTER
Alerkan, Ltd.
BZG
Mar 7, 2011K100928MICRO DIARY SPIROMETER
Viasys Respiratory Care, Inc.
BZG
Feb 10, 2011K101873MASTERSCREEN IOS
Carefusion Germany 234 GmbH, DE
BZG
Oct 16, 2010K100687VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
Vitalograph (Ireland) , Ltd., IE
BZG
Jul 16, 2010K092813ASTRASONIC SPIROMETER, MODEL 29-8000
Sdi Diagnostics, Inc.
BZG

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