K851486 is an FDA 510(k) clearance for the GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Gould, Inc. (Oxnard, US). The FDA issued a Cleared decision on October 17, 1985, 185 days after receiving the submission on April 15, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K851486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1985 |
| Decision Date | October 17, 1985 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2850 |