BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇺 Australia

    PORTABLE LIMB LOAD MONITOR (BMLLM-100)

    K Number: K915326 · Decision Oct 20, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    333

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    Basic Information

    Device Name
    PORTABLE LIMB LOAD MONITOR (BMLLM-100)
    K Number
    K915326
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1615
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bar Med Pty , Ltd.
    Date Received
    November 22, 1991
    Decision Date
    October 20, 1992
    Product Code
    IKE
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IKE Transducer, Miniature Pressure

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