GE Healthcare Finland Oy - FDA 510(k) Cleared Devices
Recent clearances: Carescape ONE, Carescape Canvas 1000, CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
32
Total
32
Cleared
0
Denied
FDA 510(k) Regulatory Record - GE Healthcare Finland Oy Anesthesiology ✕
15 devices
Cleared
Oct 21, 2021
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
Anesthesiology
185d
Cleared
May 01, 2019
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
Anesthesiology
145d
Cleared
Aug 17, 2017
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
Anesthesiology
134d
Cleared
Jul 17, 2015
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
Anesthesiology
165d
Cleared
Sep 27, 2013
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
Anesthesiology
29d
Cleared
Feb 28, 2013
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
Anesthesiology
140d
Cleared
CT
Aug 02, 2011
TRUSIGNAL R SPO2 PEDITIP SENSOR
Anesthesiology
217d
Cleared
Jun 10, 2011
NAVIGATOR APPLICATIONS SUITE
Anesthesiology
291d
Cleared
Oct 04, 2010
TRUSIGNAL SPO2 FINGERTIP SENSOR
Anesthesiology
90d
Cleared
CT
Mar 12, 2010
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP...
Anesthesiology
84d
Cleared
Apr 30, 2009
GE DATEX-OHMEDA S/5 ADU CARESTATION
Anesthesiology
30d
Cleared
Apr 01, 2009
NAVIGATOR APPLICATIONS SUITE
Anesthesiology
166d