The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Carescape B650, E-musb.
| Device ID | K213181 |
| 510k Number | K213181 |
| Device Name: | CARESCAPE B650, E-musb |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki, FI Fi-00510 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki, FI Fi-00510 |
| Product Code | MHX |
| Subsequent Product Code | BZK |
| Subsequent Product Code | BZL |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CAP |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682146111 | K213181 | 000 |
| 00840682145435 | K213181 | 000 |