BSZ · Class II · 21 CFR 868.5160

FDA Product Code BSZ: Gas-machine, Anesthesia

Leading manufacturers include Draeger Medical, Inc., Datex-Ohmeda, Inc. and Ohmeda Medical.

189
Total
189
Cleared
147d
Avg days
1976
Since
189 devices
49–72 of 189
Cleared Feb 04, 2005
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
K050055
Datex-Ohmeda, Inc.
Anesthesiology · 24d
Cleared Nov 26, 2004
PRIMUS US
K042607
Draeger Medical, Inc.
Anesthesiology · 63d
Cleared Oct 08, 2004
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
K042419
Draeger Medical, Inc.
Anesthesiology · 31d
Cleared Oct 07, 2004
BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
K041430
Blease Medical Equipment , Ltd.
Anesthesiology · 132d
Cleared Aug 31, 2004
FABIUS GS ANESTHESIA SYSTEM
K042086
Draeger Medical, Inc.
Anesthesiology · 28d
Cleared Aug 31, 2004
GE DATEX-OHMEDA AISYS CARESTATION
K042154
Datex-Ohmeda, Inc.
Anesthesiology · 21d
Cleared Jul 08, 2004
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K041622
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared Apr 26, 2004
NARKOMED 6400, MODEL NM6400
K033498
Draeger Medical, Inc.
Anesthesiology · 173d
Cleared Apr 22, 2004
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K040743
Datex-Ohmeda, Inc.
Anesthesiology · 30d
Cleared Mar 17, 2004
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K030624
Draeger Medical, Inc.
Anesthesiology · 384d
Cleared Mar 10, 2004
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K032803
Datex-Ohmeda
Anesthesiology · 183d
Cleared Jul 15, 2003
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
K030939
Philips Medical Systems
Anesthesiology · 112d
Cleared Jul 15, 2003
FABIUS TIRO ANESTHESIA SYSTEM
K031400
Draeger Medical, Inc.
Anesthesiology · 71d
Cleared Aug 29, 2002
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
K022031
Draeger Medical, Inc.
Anesthesiology · 69d
Cleared Feb 22, 2002
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
K011404
Draeger Medical, Inc.
Anesthesiology · 290d
Cleared Jun 28, 2001
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
K003663
Spacelabs Medical, Inc.
Anesthesiology · 212d
Cleared Jan 22, 2001
NARKOMED MRI-2, MODEL NM-MRI-2
K003579
Draeger Medical, Inc.
Anesthesiology · 63d
Cleared Jun 09, 2000
NARKOMED MRI , NM-MRI
K001488
Draeger Medical, Inc.
Anesthesiology · 28d
Cleared May 26, 2000
MODIFICATION TO KION ANESTHESIA SYSTEM
K001315
Siemens Elema AB
Anesthesiology · 30d
Cleared May 11, 2000
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
K000706
Datex-Ohmeda, Inc.
Anesthesiology · 70d
Cleared Apr 25, 2000
DATES-OHMEDA AESTIVA SMARTVENT MRI
K993410
Datex-Ohmeda, Inc.
Anesthesiology · 196d
Cleared Oct 27, 1999
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
K992421
Accutron, Inc.
Anesthesiology · 98d
Cleared Sep 13, 1999
KION ANESTHESIA SYSTEM
K973971
Siemens Medical Solutions USA, Inc.
Anesthesiology · 696d
Cleared Apr 09, 1999
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
K982137
Blease Medical Equipment , Ltd.
Anesthesiology · 296d