BZG · Class II · 21 CFR 868.1840

FDA Product Code BZG: Spirometer, Diagnostic

Leading manufacturers include Mir Medical Intl. Research Srl, Vitalograph (Ireland) , Ltd. and Puritan Bennett Corp..

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 09, 2009
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
K082478
Welch Allyn, Inc.
Anesthesiology · 193d
Cleared Jan 21, 2009
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
K080921
Chest M.I., Inc.
Anesthesiology · 295d