K002816 is an FDA 510(k) clearance for the TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV, a Accessories, Blood Circuit, Hemodialysis (Class II — Special Controls, product code KOC), submitted by Transonic Systems, Inc. (Ithaca, US). The FDA issued a Cleared decision on November 22, 2000, 72 days after receiving the submission on September 11, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K002816 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 11, 2000 |
| Decision Date | November 22, 2000 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOC — Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |