Product code
DRK: Dc-defibrillator, high energy, (including paddles)
FDA product code · Class III · Cardiovascular
Key facts
| Product code | DRK |
|---|---|
| Device | Dc-defibrillator, high energy, (including paddles) |
| Device class | Class III |
| Regulation number | 870.5300 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | PMA to be filed by 12/26/96 (FR 50706 (9/27/96)) |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database