MON — System, Hemodialysis, Remote Accessories Class I
FDA product code MON covers "System, Hemodialysis, Remote Accessories", a Class I medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- MON
- Device Class
- Class I
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No