NIH — Disinfectant, Subsystem, Water Purification Class II
FDA product code NIH covers "Disinfectant, Subsystem, Water Purification", a Class II medical device regulated under 21 CFR 876.5665. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NIH
- Device Class
- Class II
- Regulation Number
- 876.5665
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Disinfectant intended for reprocessing water purification systems for hemodialysis.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K133724 | medivators | MINNCARE HD | August 27, 2014 |