Dc-Defibrillator, High Energy, (Including Paddles)
FDA product code DRK · Class III (high risk) · 21 CFR 870.5300 · Cardiovascular
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934067 | Powrpak Replacement Batteries for Phisio-Control Lifepak 5/10DRK · Traditional | National Custom Ent., Inc. | 10/07/1993SE |