K192398 is an FDA 510(k) clearance for the Millenium HX. This device is classified as a Subsystem, Water Purification (Class II - Special Controls, product code FIP).
Submitted by Mar Cor Purification, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 3, 2019, 30 days after receiving the submission on September 3, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K192398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2019 |
| Decision Date | October 03, 2019 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIP - Subsystem, Water Purification |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |