K901478 is an FDA 510(k) clearance for the DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Delmed, Inc. (Concord, US). The FDA issued a Cleared decision on July 27, 1990, 122 days after receiving the submission on March 27, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K901478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1990 |
| Decision Date | July 27, 1990 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |