← FDA Medical Device Classifications
Analyzer, Pacemaker Generator Function
DTC · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3630
Classification
- FDA Product Code
DTC- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.3630
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 30
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown