K920977 is an FDA 510(k) clearance for the MERITRANS(TM) DISPOSABLE TRANSDUCER. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 11, 1992, 284 days after receiving the submission on March 2, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K920977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1992 |
| Decision Date | December 11, 1992 |
| Days to Decision | 284 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2850 |