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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