Medical Device Manufacturer · US , Tewksbury , MA

Datex-Ohmeda

41 submissions · 41 cleared · Since 2000
41
Total
41
Cleared
0
Denied

Datex-Ohmeda — FDA 510(k) Submissions

Datex-Ohmeda has submitted 41 FDA 510(k) premarket notifications since 2000, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), System, Network And Communication, Physiological Monitors, Filter, Bacterial, Breathing-circuit, Gas-machine, Anesthesia, Analyzer, Gas, Carbon-dioxide, Gaseous-phase . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
Novii+ Wireless Patch System
K231964 · HGM System, Monitoring,... · Obstetrics & Gynecology
Dec 2023 158d
GE DATEX-OHMEDA AVANCE CS2
K131945 · BSZ Gas-machine, Anesthesia · Anesthesiology
Aug 2013 42d
AESPIRE 7900, AESPIRE VIEW
K122445 · BSZ Gas-machine, Anesthesia · Anesthesiology
Oct 2012 63d
ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
K111116 · CBK Ventilator, Continuous,... · Anesthesiology
Sep 2011 141d
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
K071142 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jun 2007 43d
DATEX-OHMEDA OXY-AFR SENSOR
K042891 · NLF Oximeter, Reprocessed · Anesthesiology
Jun 2005 253d
COMPATIBILITY ECG TRUNK CABLES
K043572 · DSA Cable, Transducer And... · Cardiovascular
Feb 2005 57d
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES
K043551 · MHX Monitor, Physiological,... · Cardiovascular
Feb 2005 57d
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
K043276 · MHX Monitor, Physiological,... · Cardiovascular
Dec 2004 27d
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
K042771 · MSX System, Network And... · Cardiovascular
Oct 2004 10d
DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
K041772 · MHX Monitor, Physiological,... · Cardiovascular
Jul 2004 27d
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
K041790 · MHX Monitor, Physiological,... · Cardiovascular
Jul 2004 21d
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
K032803 · BSZ Gas-machine, Anesthesia · Anesthesiology
Mar 2004 183d
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
K033281 · MSX System, Network And... · Cardiovascular
Nov 2003 43d
DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE
K033078 · MSX System, Network And... · Cardiovascular
Oct 2003 30d
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990 · CAH Filter, Bacterial,... · General Hospital
Jun 2003 89d
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
K031781 · MHX Monitor, Physiological,... · Cardiovascular
Jun 2003 15d
DATEX-OHMEDA HMEF 750
K031653 · CAH Filter, Bacterial,... · General Hospital
Jun 2003 23d
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812 · MHX Monitor, Physiological,... · Cardiovascular
May 2003 68d
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
K023454 · CCK Analyzer, Gas,... · Anesthesiology
Apr 2003 190d
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES
K023459 · OLW Index-generating... · Neurology
Jan 2003 90d
DATEX-OHMEDA HMEF MINI
K023641 · CAH Filter, Bacterial,... · General Hospital
Nov 2002 28d
DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE
K022740 · MLD Monitor, St Segment With... · Cardiovascular
Nov 2002 87d
DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
K023497 · MSX System, Network And... · Cardiovascular
Nov 2002 17d
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE
K022485 · MHX Monitor, Physiological,... · Cardiovascular
Oct 2002 66d
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