| Device Type ID | 879 |
| Device Name | Monitor, St Segment With Alarm |
| Regulation Description | Arrhythmia Detector And Alarm (including ST-segment Measurement And Alarm). |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1025 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MLD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |