OAC — Plethysmograph, Air Displacement For Body Composition Analysis Class II
FDA product code OAC covers "Plethysmograph, Air Displacement For Body Composition Analysis", a Class II medical device regulated under 21 CFR 870.2770. Submissions are reviewed by the Cardiovascular panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OAC
- Device Class
- Class II
- Regulation Number
- 870.2770
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).