BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

    K Number: K221782 · Decision Mar 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    1
    Review Days
    269

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    Basic Information

    Device Name
    Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
    K Number
    K221782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Pte. , Ltd.
    Date Received
    June 21, 2022
    Decision Date
    March 17, 2023
    Product Code
    DRS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRS Transducer, Blood-Pressure, Extravascular

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