The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Carescape Monitor B650.
| Device ID | K102239 |
| 510k Number | K102239 |
| Device Name: | CARESCAPE MONITOR B650 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Contact | Paivi Roiha |
| Correspondent | Paivi Roiha GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2010-10-18 |
| Summary: | summary |