FDA 510(k) Applications Submitted by GE HEALTHCARE FINLAND OY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K090892 |
03/31/2009 |
GE DATEX-OHMEDA S/5 ADU CARESTATION |
GE HEALTHCARE FINLAND OY |
| K071097 |
04/18/2007 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
| K081941 |
07/08/2008 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
| K083098 |
10/17/2008 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
| K171028 |
04/05/2017 |
CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories |
GE Healthcare Finland OY |
| K211171 |
04/19/2021 |
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories |
GE Healthcare Finland Oy |
| K131223 |
04/30/2013 |
CARESCAPE MONITOR B650 |
GE HEALTHCARE FINLAND OY |
| K191149 |
04/30/2019 |
CARESCAPE B650 |
GE Healthcare Finland Oy |
| K191249 |
05/09/2019 |
CARESCAPE B450 |
GE Healthcare Finland Oy |
| K191322 |
05/15/2019 |
E-EEGX, N-EEGX |
GE Healthcare Finland Oy |
| K191323 |
05/15/2019 |
Carescape B850 |
GE Healthcare Finland OY |
| K131414 |
05/16/2013 |
CARESCAPE MONITOR B850 |
GE HEALTHCARE FINLAND OY |
| K132528 |
08/12/2013 |
E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES |
GE HEALTHCARE FINLAND OY |
| K132533 |
08/12/2013 |
CARESCAPE MONITOR B450 |
GE HEALTHCARE FINLAND OY |
| K132696 |
08/29/2013 |
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR |
GE HEALTHCARE FINLAND OY |
| K213181 |
09/29/2021 |
CARESCAPE B650, E-musb |
GE Healthcare Finland Oy |
| K213336 |
10/06/2021 |
Carescape B850, E-musb |
GE Healthcare Finland OY |
| K213363 |
10/12/2021 |
CARESCAPE B450, E-musb |
GE Healthcare Finland Oy |
| K223531 |
11/23/2022 |
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) |
GE Healthcare Finland Oy |
| K183394 |
12/07/2018 |
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO |
GE Healthcare Finland Oy |
| K143676 |
12/24/2014 |
B40i Patient Monitor |
GE HEALTHCARE FINLAND OY |
| K081870 |
07/01/2008 |
MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO |
GE HEALTHCARE FINLAND OY |
| K150245 |
02/02/2015 |
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX |
GE HEALTHCARE FINLAND OY |
| K102389 |
08/23/2010 |
NAVIGATOR APPLICATIONS SUITE |
GE HEALTHCARE FINLAND OY |
| K102239 |
08/09/2010 |
CARESCAPE MONITOR B650 |
GE HEALTHCARE FINLAND OY |
| K092680 |
09/01/2009 |
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN |
GE HEALTHCARE FINLAND OY |
| K123195 |
10/11/2012 |
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES |
GE HEALTHCARE FINLAND OY |
| K103802 |
12/28/2010 |
TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR |
GE HEALTHCARE FINLAND OY |
| K101871 |
07/06/2010 |
TRUSIGNAL SPO2 FINGERTIP SENSOR |
GE HEALTHCARE FINLAND OY |
| K093881 |
12/18/2009 |
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR |
GE HEALTHCARE FINLAND OY |
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