| Device Type ID | 771 |
| Device Name | Alarm, Leakage Current, Portable |
| Regulation Description | Portable Leakage Current 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) Exempt |
| CFR Regulation Number | 870.2640 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DSM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 771 |
| Device | Alarm, Leakage Current, Portable |
| Product Code | DSM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Portable Leakage Current Alarm. |
| CFR Regulation Number | 870.2640 [🔎] |