K221782 is an FDA 510(k) clearance for the Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Merit Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on March 17, 2023, 269 days after receiving the submission on June 21, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K221782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2022 |
| Decision Date | March 17, 2023 |
| Days to Decision | 269 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 |