Device Type ID | 785 |
Device Name | Magnet, Test, Pacemaker |
Regulation Description | Pacemaker Test Magnet. |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Implantable Electrophysical Devices Branch (IEDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 870.3690 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | DTG |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 785 |
Device | Magnet, Test, Pacemaker |
Product Code | DTG |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Pacemaker Test Magnet. |
CFR Regulation Number | 870.3690 [🔎] |
Device Problems | |
---|---|
Accessory Incompatible | 1 |
High Capture Threshold | 1 |
Total Device Problems | 2 |