← FDA Medical Device Classifications
Warmer, Blood, Electromagnetic Radiation
BSA · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.9205
Classification
- FDA Product Code
BSA- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 864.9205
- Review panel
- HE
- Medical specialty
- Hematology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown