The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Carescape Monitor B850.
| Device ID | K092027 |
| 510k Number | K092027 |
| Device Name: | CARESCAPE MONITOR B850 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 86 PILGRIN RD. Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 86 PILGRIN RD. Needham, MA 02492 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-08-28 |
| Summary: | summary |