JWO — Device, Blood Volume Measuring Class II
FDA product code JWO covers "Device, Blood Volume Measuring", a Class II medical device regulated under 21 CFR 864.5950. Submissions are reviewed by the Hematology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JWO
- Device Class
- Class II
- Regulation Number
- 864.5950
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No