BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER

    K Number: K110646 · Decision Oct 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    222

    Basic Information

    Device Name
    BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER
    K Number
    K110646
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1180
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BEAM-MED LTD
    Date Received
    March 4, 2011
    Decision Date
    October 12, 2011
    Product Code
    MUA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUA Bone Sonometer

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