FOA — Board, Cardiopulmonary Class I
FDA product code FOA covers "Board, Cardiopulmonary", a Class I medical device regulated under 21 CFR 880.6080. Submissions are reviewed by the General Hospital panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FOA
- Device Class
- Class I
- Regulation Number
- 880.6080
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No