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

    MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE

    K Number: K854734 · Decision Feb 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    44
    Applicant Total
    19
    Review Days
    77

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    Basic Information

    Device Name
    MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
    K Number
    K854734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medasonics, Inc.
    Date Received
    November 25, 1985
    Decision Date
    February 10, 1986
    Product Code
    DRM
    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
    DRM Compressor, Cardiac, External

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