| Device |
dc-defibrillator, high energy, (including paddles) |
| Regulation Description |
DC-defribrillator (including paddles). |
| Definition |
Pma to be filed by 12/26/96 (fr 50706 (9/27/96)). |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
| Product Code | DRK |
| Submission Type |
PMA
|
| Regulation Number |
870.5300
|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|