PHY — Sparse Sample Pk Profile And Dosing Software Class II
FDA product code PHY covers "Sparse Sample Pk Profile And Dosing Software", a Class II medical device regulated under 21 CFR 868.1890. Submissions are reviewed by the Anesthesiology panel.
Classification Details
- Product Code
- PHY
- Device Class
- Class II
- Regulation Number
- 868.1890
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
To estimate PK profile and dosing calculation.