← FDA Medical Device Classifications
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
DRO · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5550
Classification
- FDA Product Code
DRO- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.5550
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- Y
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 84
- Registered establishments
- 21
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown