The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Carescape V100.
| Device ID | K073203 |
| 510k Number | K073203 |
| Device Name: | CARESCAPE V100 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORP.BLVD. Tampa, FL 33614 |
| Contact | Karen Russell |
| Correspondent | Karen Russell GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 4502 WOODLAND CORP.BLVD. Tampa, FL 33614 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2007-11-29 |
| Summary: | summary |