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 Jan 22, 2008
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
K072420
Oceanic Medical Products, Inc.
Anesthesiology · 147d
Cleared Oct 10, 2007
NAVIGATOR APPLICATIONS SUITE
K071097
GE Healthcare Finland Oy
Anesthesiology · 175d
Cleared Jun 06, 2007
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
K071142
Datex-Ohmeda
Anesthesiology · 43d
Cleared Feb 22, 2007
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
K062388
Docusys
Anesthesiology · 191d
Cleared Nov 09, 2006
DIGITAL MXR-D FLOWMETER
K062155
Porter Instrument Co., Inc.
Anesthesiology · 104d
Cleared Jul 28, 2006
PRIMA ANAESTHESIA MACHINE
K061102
Penlon , Ltd.
Anesthesiology · 100d
Cleared Jun 27, 2006
GE DATEX-OHMEDA AISYS
K061609
Datex-Ohmeda, Inc.
Anesthesiology · 18d
Cleared Apr 10, 2006
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
K060193
Oceanic Medical Products, Inc.
Anesthesiology · 75d
Cleared Nov 23, 2005
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
K052335
Accutron, Inc.
Anesthesiology · 89d
Cleared Nov 04, 2005
SAFERSLEEP SYSTEM
K050883
Safer Sleep, LLC
Anesthesiology · 211d
Cleared Sep 23, 2005
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
K051629
Blease USA, Inc.
Anesthesiology · 95d
Cleared Apr 12, 2005
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
K050676
Datex-Ohmeda, Inc.
Anesthesiology · 27d
Cleared Mar 25, 2005
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
K050626
Datex-Ohmeda, Inc.
Anesthesiology · 14d
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 Sep 03, 2004
MALLARD MODEL 3000 ANESTHESIA MACHINE
K033026
Mallard Medical, Inc.
Anesthesiology · 343d
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