QAF — Impedance Plethysmograph, Cranial Class II
FDA product code QAF covers "Impedance Plethysmograph, Cranial", a Class II medical device regulated under 21 CFR 870.2770. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QAF
- Device Class
- Class II
- Regulation Number
- 870.2770
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Detect or measure variations in volume in the cranium, using tissue impedance properties.