MNS · Class II · 21 CFR 868.5895

FDA Product Code MNS: Ventilator, Continuous, Non-life-supporting

Leading manufacturers include Resmed, Ltd., Respironics, Inc. and Respironics Inc., Sleep & Home Respiratory Group.

47
Total
47
Cleared
159d
Avg days
1996
Since
47 devices
25–47 of 47
Cleared Dec 22, 2009
VPAP TX
K092186
Resmed, Ltd.
Anesthesiology · 154d
Cleared Oct 30, 2009
BIPAP AUTOSV ADVANCED
K090539
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 245d
Cleared Aug 05, 2009
BIPAP SYNCHRONY 2
K092043
Respironics, Inc.
Anesthesiology · 30d
Cleared Mar 04, 2009
BIPAP AUTOSV
K090248
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 30d
Cleared Aug 08, 2007
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
K071509
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 65d
Cleared May 08, 2007
BIPAP SYNCHRONY WITH AVAPS
K070328
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 92d
Cleared Feb 22, 2007
BIPAP AUTOSV
K063540
Respironics, Inc.
Anesthesiology · 90d
Cleared Feb 20, 2007
BIPAP SYNCHRONY
K063533
Respironics, Inc.
Anesthesiology · 90d
Cleared Apr 07, 2006
VPAP III ST-A/KIDSTA MASK SYSTEM
K060105
Resmed, Ltd.
Anesthesiology · 84d
Cleared Aug 16, 2005
VPAP ADAPT
K051364
Resmed, Ltd.
Anesthesiology · 83d
Cleared Jun 07, 2004
VPAP III ST-A
K033276
Resmed, Ltd.
Anesthesiology · 241d
Cleared Jul 30, 2003
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
K031656
Respironics, Inc.
Anesthesiology · 63d
Cleared Mar 20, 2002
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
K020777
Respironics, Inc.
Anesthesiology · 9d
Cleared Dec 20, 2001
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
K012323
Respironics, Inc.
Anesthesiology · 150d
Cleared Mar 20, 2000
BIPAP SYNCHRONY HC
K992530
Respironics, Inc.
Anesthesiology · 236d
Cleared May 19, 1999
BIPAP HARMONY S/T, MODEL 1001445
K984407
Respironics, Inc.
Anesthesiology · 161d
Cleared Jun 24, 1998
SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
K974417
ResMed Corp
Anesthesiology · 212d
Cleared Feb 20, 1997
MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
K962517
Healthdyne Technologies, Inc.
Anesthesiology · 238d
Cleared Feb 09, 1996
PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM
K942210
Puritan Bennett Corp.
Anesthesiology · 647d