K894838 is an FDA 510(k) clearance for the HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB. This device is classified as a System, Dialysate Delivery, Single Patient (Class II - Special Controls, product code FKP).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 7, 1989, 38 days after receiving the submission on July 31, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K894838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1989 |
| Decision Date | September 07, 1989 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FKP — System, Dialysate Delivery, Single Patient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |