← FDA Medical Device Classifications
Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
DTY · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4410
Classification
- FDA Product Code
DTY- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.4410
- 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
- 8
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown