Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes— 510(k) K221782

Substantially Equivalent

Merit Medical Pte. , Ltd.

FDA 510(k) clearance K221782 for Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes, Substantially Equivalent on 2023-03-17. Applicant: Merit Medical Pte. , Ltd..

Clearance details

Applicant: Merit Medical Pte. , Ltd.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2022-06-21
Decision date: 2023-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.