The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Apexpro Telemetry Systems.
| Device ID | K080251 |
| 510k Number | K080251 |
| Device Name: | APEXPRO TELEMETRY SYSTEMS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Bernard Sandler |
| Correspondent | Bernard Sandler GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2008-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682109383 | K080251 | 000 |
| 00840682109260 | K080251 | 000 |
| 00840682109024 | K080251 | 000 |
| 00840682108928 | K080251 | 000 |
| 00840682108799 | K080251 | 000 |
| 00840682108775 | K080251 | 000 |