K981085 is an FDA 510(k) clearance for the GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM. This device is classified as a Subsystem, Water Purification (Class II - Special Controls, product code FIP).
Submitted by Gambro Healthcare (Lakewood, US). The FDA issued a Cleared decision on May 18, 1998, 54 days after receiving the submission on March 25, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K981085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 1998 |
| Decision Date | May 18, 1998 |
| Days to Decision | 54 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 |