The following data is part of a premarket notification filed by Medivators, Inc. with the FDA for Minncare Hd.
| Device ID | K133724 |
| 510k Number | K133724 |
| Device Name: | MINNCARE HD |
| Classification | Disinfectant, Subsystem, Water Purification |
| Applicant | MEDIVATORS, INC. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Kinnari Shah |
| Correspondent | Kinnari Shah MEDIVATORS, INC. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | NIH |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-06 |
| Decision Date | 2014-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30677964066888 | K133724 | 000 |
| 30677964066895 | K133724 | 000 |
| 30677964079499 | K133724 | 000 |
| 30677964066871 | K133724 | 000 |
| 30677964066864 | K133724 | 000 |
| 50724995223293 | K133724 | 000 |