DRK — Dc-Defibrillator, High Energy, (Including Paddles) Class III
FDA product code DRK covers "Dc-Defibrillator, High Energy, (Including Paddles)", a Class III medical device regulated under 21 CFR 870.5300. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- DRK
- Device Class
- Class III
- Regulation Number
- 870.5300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K934067 | national custom ent | POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 | October 7, 1993 |