510(k) K221782

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes by Merit Medical Pte. , Ltd. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2023
Date Received
June 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type