Medical Device Manufacturer · US , Tewksbury , MA

Datex-Ohmeda - FDA 510(k) Cleared Devices

41 submissions · 41 cleared · Since 2000
41
Total
41
Cleared
0
Denied
41 devices
26-41 of 41
Cleared Aug 30, 2002
DATEX-OHMEDA HMEF 500
K021265 · CAH
General Hospital · 130d
Cleared Aug 23, 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507 · MSX
Cardiovascular · 24d
Cleared Jul 24, 2002
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K021376 · DSI
Cardiovascular · 84d
Cleared Jul 19, 2002
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
K021279 · MHX
Cardiovascular · 88d
Cleared Mar 26, 2002
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
K020479 · DQA
Anesthesiology · 41d
Cleared Jan 10, 2002
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES
K013389 · OLW
Neurology · 90d
Cleared Jan 08, 2002
DATEX-OHMEDA S/5 WEB VIEWER
K013387 · MSX
Cardiovascular · 88d
Cleared Dec 11, 2001
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
K013246 · MSX
Cardiovascular · 74d
Cleared Nov 02, 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · MSX
Cardiovascular · 88d
Cleared Sep 14, 2001
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · MLD
Cardiovascular · 22d
Cleared Jun 26, 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH...
K011670 · DQA
Anesthesiology · 27d
Cleared Aug 23, 2000
DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND...
K001814 · CCK
Anesthesiology · 69d
Cleared Jun 08, 2000
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
K000815 · MHX
Cardiovascular · 87d
Cleared Jun 05, 2000
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
K000882 · MHX
Cardiovascular · 77d
Cleared Apr 13, 2000
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
K000168 · MHX
Cardiovascular · 84d
Cleared Feb 10, 2000
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
K000186 · MRN
Anesthesiology · 27d
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