GE Healthcare Finland Oy

FDA 510(k) & PMA Approved Devices — 29 products

Total Devices29

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K260656	Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M	MHX	2026-09-01	View
510(k)	K260343	Carescape Canvas 1000; Carescape Canvas Smart Display	MHX	2026-08-28	View
510(k)	K223531	CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)	MHX	2023-04-06	View
510(k)	K213363	CARESCAPE B450, E-musb	MHX	2022-04-13	View
510(k)	K213181	CARESCAPE B650, E-musb	MHX	2022-04-13	View
510(k)	K213336	Carescape B850, E-musb	MHX	2022-04-13	View
510(k)	K211171	CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories	CCK	2021-10-21	View
510(k)	K191323	Carescape B850	MHX	2020-01-29	View
510(k)	K191249	CARESCAPE B450	MHX	2020-01-24	View
510(k)	K191322	E-EEGX, N-EEGX	OLT	2020-01-22	View
510(k)	K191149	CARESCAPE B650	MHX	2020-01-21	View
510(k)	K183394	CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO	CCK	2019-05-01	View
510(k)	K171028	CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories	CCK	2017-08-17	View
510(k)	K132533	CARESCAPE MONITOR B450	MHX	2013-12-04	View
510(k)	K132696	TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR	DQA	2013-09-27	View
510(k)	K131414	CARESCAPE MONITOR B850	MHX	2013-08-28	View
510(k)	K131223	CARESCAPE MONITOR B650	MHX	2013-08-28	View
510(k)	K123195	CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES	CCL	2013-02-28	View
510(k)	K103802	TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR	DQA	2011-08-02	View
510(k)	K102389	NAVIGATOR APPLICATIONS SUITE	BSZ	2011-06-10	View