K133724 is an FDA 510(k) clearance for the MINNCARE HD. This device is classified as a Disinfectant, Subsystem, Water Purification (Class II - Special Controls, product code NIH).
Submitted by Medivators, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 27, 2014, 264 days after receiving the submission on December 6, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 876.5665. Disinfectant Intended For Reprocessing Water Purification Systems For Hemodialysis..
| 510(k) Number | K133724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2013 |
| Decision Date | August 27, 2014 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NIH - Disinfectant, Subsystem, Water Purification |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |
| Definition | Disinfectant Intended For Reprocessing Water Purification Systems For Hemodialysis. |