DRK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dc-Defibrillator, High Energy, (Including Paddles)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5300
- Medical specialty
- Cardiovascular
- FDA definition
- PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
- Adverse events (MAUDE)
- 1994: 17 · 1995: 2 · 1998: 1 · 1999: 1 · 2005: 2 · 2008: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 (K934067) | National Custom Ent., Inc. | 1993-10-07 |
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Every clearance here is in the API, with alerts when new ones post.