K771705 is an FDA 510(k) clearance for the RS-7800 MINIPUMP. This device is classified as a Pump, Blood, Extra-luminal (Class II - Special Controls, product code FIR).
Submitted by Renal Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1977, 25 days after receiving the submission on September 9, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K771705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1977 |
| Decision Date | October 04, 1977 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FIR — Pump, Blood, Extra-luminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |