K003445 is an FDA 510(k) clearance for the FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2. This device is classified as a Protector, Transducer, Dialysis (Class II - Special Controls, product code FIB).
Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on December 1, 2000, 25 days after receiving the submission on November 6, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K003445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2000 |
| Decision Date | December 01, 2000 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIB — Protector, Transducer, Dialysis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |