The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Carescape Model V100 Vital Signs Monitor.
| Device ID | K102426 |
| 510k Number | K102426 |
| Device Name: | CARESCAPE MODEL V100 VITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Mary Carter |
| Correspondent | Mary Carter GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-25 |
| Decision Date | 2010-10-20 |
| Summary: | summary |