Medical Device Manufacturer · US , Madison , WI

GE Healthcare Finland Oy

30 submissions · 30 cleared · Since 2007
30
Total
30
Cleared
0
Denied

GE Healthcare Finland Oy — FDA 510(k) Submissions

GE Healthcare Finland Oy has submitted 30 FDA 510(k) premarket notifications since 2007, of which 30 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), Gas-machine, Anesthesia, Oximeter, Analyzer, Gas, Carbon-dioxide, Gaseous-phase, Analyzer, Gas, Oxygen, Gaseous-phase . Use the specialty filter in the sidebar to narrow results.

30 devices
1–25 of 30
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
K223531 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2023 134d
CARESCAPE B650, E-musb
K213181 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2022 196d
Carescape B850, E-musb
K213336 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2022 189d
CARESCAPE B450, E-musb
K213363 · MHX Monitor, Physiological,... · Cardiovascular
Apr 2022 183d
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
K211171 · CCK Analyzer, Gas,... · Anesthesiology
Oct 2021 185d
Carescape B850
K191323 · MHX Monitor, Physiological,... · Cardiovascular
Jan 2020 259d
CARESCAPE B450
K191249 · MHX Monitor, Physiological,... · Cardiovascular
Jan 2020 260d
E-EEGX, N-EEGX
K191322 · OLT Non-normalizing... · Neurology
Jan 2020 252d
CARESCAPE B650
K191149 · MHX Monitor, Physiological,... · Cardiovascular
Jan 2020 266d
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
K183394 · CCK Analyzer, Gas,... · Anesthesiology
May 2019 145d
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
K171028 · CCK Analyzer, Gas,... · Anesthesiology
Aug 2017 134d
B40i Patient Monitor
K143676 · MHX Monitor, Physiological,... · Cardiovascular
Jul 2015 219d
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
K150245 · CCK Analyzer, Gas,... · Anesthesiology
Jul 2015 165d
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
K132528 · DXG Computer, Diagnostic,... · Cardiovascular
Jan 2014 157d
CARESCAPE MONITOR B450
K132533 · MHX Monitor, Physiological,... · Cardiovascular
Dec 2013 114d
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
K132696 · DQA Oximeter · Anesthesiology
Sep 2013 29d
CARESCAPE MONITOR B650
K131223 · MHX Monitor, Physiological,... · Cardiovascular
Aug 2013 120d
CARESCAPE MONITOR B850
K131414 · MHX Monitor, Physiological,... · Cardiovascular
Aug 2013 104d
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
K123195 · CCL Analyzer, Gas, Oxygen,... · Anesthesiology
Feb 2013 140d
TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR
K103802 · DQA Oximeter · Anesthesiology
Aug 2011 217d
NAVIGATOR APPLICATIONS SUITE
K102389 · BSZ Gas-machine, Anesthesia · Anesthesiology
Jun 2011 291d
CARESCAPE MONITOR B650
K102239 · MHX Monitor, Physiological,... · Cardiovascular
Oct 2010 70d
TRUSIGNAL SPO2 FINGERTIP SENSOR
K101871 · DQA Oximeter · Anesthesiology
Oct 2010 90d
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
K093881 · DQA Oximeter · Anesthesiology
Mar 2010 84d
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN
K092680 · MHX Monitor, Physiological,... · Cardiovascular
Sep 2009 22d
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