K041163 is an FDA 510(k) clearance for the ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES. This device is classified as a Subsystem, Water Purification (Class II - Special Controls, product code FIP).
Submitted by Isopure, Corp. (Simpsonville, US). The FDA issued a Cleared decision on October 7, 2004, 157 days after receiving the submission on May 3, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K041163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2004 |
| Decision Date | October 07, 2004 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FIP - Subsystem, Water Purification |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |