GE Healthcare Finland Oy
Dispositifs autorisés FDA 510(k) et PMA — 13 produits
Publicité
Nombre total de dispositifs13
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | 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 | Voir |
| 510(k) | K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | MHX | 2026-08-28 | Voir |
| 510(k) | K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | MHX | 2023-04-06 | Voir |
| 510(k) | K213181 | CARESCAPE B650, E-musb | MHX | 2022-04-13 | Voir |
| 510(k) | K213336 | Carescape B850, E-musb | MHX | 2022-04-13 | Voir |
| 510(k) | K213363 | CARESCAPE B450, E-musb | MHX | 2022-04-13 | Voir |
| 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 | Voir |
| 510(k) | K191323 | Carescape B850 | MHX | 2020-01-29 | Voir |
| 510(k) | K191249 | CARESCAPE B450 | MHX | 2020-01-24 | Voir |
| 510(k) | K191322 | E-EEGX, N-EEGX | OLT | 2020-01-22 | Voir |
| 510(k) | K191149 | CARESCAPE B650 | MHX | 2020-01-21 | Voir |
| 510(k) | K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | CCK | 2019-05-01 | Voir |
| 510(k) | K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories | CCK | 2017-08-17 | Voir |
Aucun dispositif correspondant.