BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GS-128 GRADIENT COMPRESSION SYSTEM

    K Number: K050584 · Decision Mar 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    1
    Review Days
    15

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    Basic Information

    Device Name
    GS-128 GRADIENT COMPRESSION SYSTEM
    K Number
    K050584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medmark Technologies, LLC
    Date Received
    March 7, 2005
    Decision Date
    March 22, 2005
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    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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