| Device Type ID | 751 |
| Device Name | Tester, Defibrillator |
| Regulation Description | Defibrillator Tester. |
| 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 | 870.5325 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 751 |
| Device | Tester, Defibrillator |
| Product Code | DRL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Defibrillator Tester. |
| CFR Regulation Number | 870.5325 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BC GROUP INTERNATIONAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BC Group International Inc | III | Dec-22-2015 |