| Device Type ID | 749 |
| Device Name | System, Signal Isolation |
| Regulation Description | Signal Isolation System. |
| 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 | 870.2600 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DRJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 749 |
| Device | System, Signal Isolation |
| Product Code | DRJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Signal Isolation System. |
| CFR Regulation Number | 870.2600 [🔎] |