K082758 is an FDA 510(k) clearance for the PRISMAFLO II. This device is classified as a Accessories, Blood Circuit, Hemodialysis (Class II - Special Controls, product code KOC).
Submitted by Stihler Electronic GmbH (Sound Beach, US). The FDA issued a Cleared decision on December 19, 2008, 91 days after receiving the submission on September 19, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K082758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2008 |
| Decision Date | December 19, 2008 |
| Days to Decision | 91 days |
| Submission Type | Special |
| 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 |