Cleared Traditional

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

K221782 · Merit Medical Pte. , Ltd. · Cardiovascular

Mar 2023

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K221782 is an FDA 510(k) clearance for the Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes, 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 review panel. Regulated under 21 CFR 870.2850.

Submission Details

510(k) Number	K221782 FDA.gov
FDA Decision	Cleared 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