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

    Ezlymph, Ezlymph M

    K Number: K193662 · Decision Feb 11, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    2
    Review Days
    408

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    Basic Information

    Device Name
    Ezlymph, Ezlymph M
    K Number
    K193662
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eezcare Medical Corp
    Date Received
    December 31, 2019
    Decision Date
    February 11, 2021
    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
    K191937 Ezvena IPC, Ezvena SQS