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GE Healthcare Finland Oy

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories3
Latest FDA decision2023-04-06
TypeNumberDevice NameCodeDateActions
510(k) K223531 CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)MHX2023-04-06 View
510(k) K213336 Carescape B850, E-musbMHX2022-04-13 View
510(k) K213181 CARESCAPE B650, E-musbMHX2022-04-13 View
510(k) K213363 CARESCAPE B450, E-musbMHX2022-04-13 View
510(k) K211171 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessoriesCCK2021-10-21 View
510(k) K191323 Carescape B850MHX2020-01-29 View
510(k) K191249 CARESCAPE B450MHX2020-01-24 View
510(k) K191322 E-EEGX, N-EEGXOLT2020-01-22 View
510(k) K191149 CARESCAPE B650MHX2020-01-21 View
510(k) K183394 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOCCK2019-05-01 View
510(k) K171028 CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesCCK2017-08-17 View
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