Medical Device Manufacturer · US , Madison , WI

Datex-Ohmeda, Inc. - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 1998
60
Total
60
Cleared
0
Denied
45 devices
26-45 of 45
Cleared Feb 04, 2005
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
K050055 · BSZ
Anesthesiology · 24d
Cleared Oct 26, 2004
GE DATEX-OHMEDA ENGSTROM CARESTATION
K041775 · CBK
Anesthesiology · 117d
Cleared Sep 20, 2004
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
K041524 · CBK
Anesthesiology · 104d
Cleared Sep 02, 2004
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K040831 · DPZ
Anesthesiology · 155d
Cleared Aug 31, 2004
GE DATEX-OHMEDA AISYS CARESTATION
K042154 · BSZ
Anesthesiology · 21d
Cleared Apr 22, 2004
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K040743 · BSZ
Anesthesiology · 30d
Cleared Oct 07, 2003
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
K023366 · CBK
Anesthesiology · 364d
Cleared Jun 26, 2003
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
K031027 · CAD
Anesthesiology · 86d
Cleared Oct 08, 2002
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES...
K021955 · DQA
Anesthesiology · 116d
Cleared Jan 30, 2002
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
K012924 · CAD
Anesthesiology · 152d
Cleared Mar 15, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · DQA
Anesthesiology · 27d
Cleared Sep 21, 2000
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
K002878 · CAD
Anesthesiology · 6d
Cleared Jun 30, 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · DQA
Anesthesiology · 28d
Cleared May 11, 2000
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
K000706 · BSZ
Anesthesiology · 70d
Cleared Apr 25, 2000
DATES-OHMEDA AESTIVA SMARTVENT MRI
K993410 · BSZ
Anesthesiology · 196d
Cleared Apr 12, 2000
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD...
K000275 · CAD
Anesthesiology · 72d
Cleared Mar 31, 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K993512 · DQA
Anesthesiology · 165d
Cleared Mar 15, 2000
DATEX-OHMEDA TONOMETRY MODULE M-TONO
K993656 · CCK
Anesthesiology · 138d
Cleared Jan 21, 1999
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
K990132 · CAD
Anesthesiology · 7d
Cleared Nov 06, 1998
DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
K983684 · DQA
Anesthesiology · 17d
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