Device Type ID | 1035 |
Device Name | Batteries, Rechargeable, For Class 2 Devices |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Implantable Electrophysical Devices Branch (IEDB) |
Submission Type | 510(k) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | MOX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1035 |
Device | Batteries, Rechargeable, For Class 2 Devices |
Product Code | MOX |
Device Problems | |
---|---|
Complete Loss Of Power | 1 |
Battery | 1 |
Total Device Problems | 2 |