BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Ezvena IPC, Ezvena SQS

    K Number: K191937 · Decision Jan 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    2
    Review Days
    194

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    Basic Information

    Device Name
    Ezvena IPC, Ezvena SQS
    K Number
    K191937
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eezcare Medical Corp
    Date Received
    July 19, 2019
    Decision Date
    January 29, 2020
    Product Code
    JOW
    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
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Eezcare Medical Corp

    K Number Device Name
    K193662 Ezlymph, Ezlymph M