BZG · Class II · 21 CFR 868.1840

FDA Product Code BZG: Spirometer, Diagnostic

Leading manufacturers include Vitalograph (Ireland) , Ltd., Mir Medical Intl. Research Srl and Sdi Diagnostics, Inc..

228
Total
228
Cleared
165d
Avg days
1977
Since
228 devices
25–48 of 228
Cleared Aug 26, 2016
Vitalograph Model 6300 micro
K160253
Vitalograph (Ireland) , Ltd.
Anesthesiology · 207d
Cleared Jan 12, 2016
IQSense Flow Sensor Mouthpiece
K150515
Sdi Diagnostics, Inc.
Anesthesiology · 316d
Cleared Jun 30, 2015
Vitalograph Model 6600 Compact
K142642
Vitalograph (Ireland) , Ltd.
Anesthesiology · 286d
Cleared Jun 29, 2015
Vitalograph Model 6800 Pneumotrac
K142812
Vitalograph (Ireland) , Ltd.
Anesthesiology · 273d
Cleared Jun 24, 2015
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
K120577
Medikro OY
Anesthesiology · 1213d
Cleared May 27, 2015
SpiroThor
K150137
Cohero Health, LLC
Anesthesiology · 125d
Cleared Mar 06, 2015
PULMONE MINIBOXPFT 2.0
K141793
Pulmone Advanced Medical Devices, Ltd.
Anesthesiology · 247d
Cleared Dec 29, 2014
MICROBLAB, MICROLOOP
K141936
Carefusion Germany 234 GmbH
Anesthesiology · 165d
Cleared Nov 20, 2014
NeumoFilt Ergo/Neumo Filt BiteOn
K142303
Medical Respiratory Devices S.L.
Anesthesiology · 94d
Cleared Sep 03, 2014
VITALOGRAPH MODEL 7000 SPIROTRAC
K141546
Vitalograph (Ireland) , Ltd.
Anesthesiology · 85d
Cleared May 21, 2014
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
K133428
Medikro OY
Anesthesiology · 194d
Cleared May 08, 2014
ASTHMA MONITOR AM3
K133722
Eresearch Technology
Anesthesiology · 154d
Cleared Nov 15, 2013
SPM-300
K130322
Bionet Co., Ltd.
Anesthesiology · 280d
Cleared Oct 30, 2013
SPIROTEL
K130784
Mir Medical Intl. Research Srl
Anesthesiology · 223d
Cleared Sep 10, 2013
CCS-200 SPIROMETER
K123896
Benson Medical Instruments Co.
Anesthesiology · 266d
Cleared Oct 04, 2012
MINISPIR
K122384
Mir Medical Intl. Research Srl
Anesthesiology · 59d
Cleared Apr 19, 2012
ORBIT
K120880
National Biomedical, LLC Dba Qrs Diagnostic
Anesthesiology · 27d
Cleared Apr 13, 2012
MICRO I
K113096
Carefusion Germany 234 GmbH
Anesthesiology · 177d
Cleared Nov 21, 2011
SPIRODOC
K103530
Medical International Research USA, Inc.
Anesthesiology · 355d
Cleared Nov 10, 2011
CHARTIS CONSOLE
K111764
Pulmonx, Inc.
Anesthesiology · 140d
Cleared Nov 09, 2011
SPIRO PD
K103575
Pmd Healthcare
Anesthesiology · 338d
Cleared Oct 20, 2011
ALERKAN SPIROMETRY FILTER
K111587
Alerkan, Ltd.
Anesthesiology · 135d
Cleared Mar 07, 2011
MICRO DIARY SPIROMETER
K100928
Viasys Respiratory Care, Inc.
Anesthesiology · 336d
Cleared Feb 10, 2011
MASTERSCREEN IOS
K101873
Carefusion Germany 234 GmbH
Anesthesiology · 219d