K133149 is an FDA 510(k) clearance for the BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM. 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 April 30, 2014, 195 days after receiving the submission on October 17, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K133149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2013 |
| Decision Date | April 30, 2014 |
| Days to Decision | 195 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 |