K925978 is an FDA 510(k) clearance for the MPC-80 TRANSDUCER, a Protector, Transducer, Dialysis (Class II — Special Controls, product code FIB), submitted by Molded Products, Inc. (Harlan, US). The FDA issued a Cleared decision on January 14, 1994, 415 days after receiving the submission on November 25, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K925978 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 1992 |
| Decision Date | January 14, 1994 |
| Days to Decision | 415 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FIB — Protector, Transducer, Dialysis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |