K961465 is an FDA 510(k) clearance for the 2008H ON LINE CLEARANCE MONITOR, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on July 3, 1997, 442 days after receiving the submission on April 17, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K961465 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 17, 1996 |
| Decision Date | July 03, 1997 |
| Days to Decision | 442 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5860 |