FDA product code DRK
Dc-Defibrillator, High Energy, (Including Paddles)
Cardiovascular·Class 3·21 CFR 870.5300
US regulatory classifications
- US Product Code (FDA)
- DRKView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 870.5300View CFR Regulation →
- Medical specialty
- Cardiovascular
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
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About this record
Dc-Defibrillator, High Energy, (Including Paddles) is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.