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

FDA 510(k) cleared devices by Datex-Ohmeda Cardiovascular

23 devices
1-23 of 23
Cleared Feb 22, 2005
COMPATIBILITY ECG TRUNK CABLES
K043572 · DSA
Cardiovascular · 57d
Cleared Feb 18, 2005
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND...
K043551 · MHX
Cardiovascular · 57d
Cleared Dec 23, 2004
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
K043276 · MHX
Cardiovascular · 27d
Cleared Oct 15, 2004
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
K042771 · MSX
Cardiovascular · 10d
Cleared Jul 28, 2004
DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
K041772 · MHX
Cardiovascular · 27d
Cleared Jul 23, 2004
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
K041790 · MHX
Cardiovascular · 21d
Cleared Nov 26, 2003
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
K033281 · MSX
Cardiovascular · 43d
Cleared Oct 29, 2003
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
K033078 · MSX
Cardiovascular · 30d
Cleared Jun 25, 2003
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
K031781 · MHX
Cardiovascular · 15d
Cleared May 21, 2003
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812 · MHX
Cardiovascular · 68d
Cleared Nov 14, 2002
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A...
K022740 · MLD
Cardiovascular · 87d
Cleared Nov 04, 2002
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497 · MSX
Cardiovascular · 17d
Cleared Oct 03, 2002
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
K022485 · MHX
Cardiovascular · 66d
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 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 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
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