K182367 is an FDA 510(k) clearance for the DIASAFEplusUS. This device is classified as a Subsystem, Water Purification (Class II - Special Controls, product code FIP).
Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on January 10, 2019, 132 days after receiving the submission on August 31, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K182367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2018 |
| Decision Date | January 10, 2019 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| 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 |