K850435 is an FDA 510(k) clearance for the SARTORIUS AQUASART SM 40035 - DIALYSATE SYS. This device is classified as a Subsystem, Proportioning (Class II - Special Controls, product code FKR).
Submitted by Sartorius Filters, Inc. (Hayward, US). The FDA issued a Cleared decision on June 4, 1985, 120 days after receiving the submission on February 4, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K850435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1985 |
| Decision Date | June 04, 1985 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKR — Subsystem, Proportioning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |