← FDA Medical Device Classifications
Dc-Defibrillator, High Energy, (Including Paddles)
DRK · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.5300
Classification
- FDA Product Code
DRK- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 870.5300
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown