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

    UltraScan 650

    K Number: K161919 · Decision Apr 5, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    UltraScan 650
    K Number
    K161919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1180
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cyberlogic, Inc.
    Date Received
    July 13, 2016
    Decision Date
    April 5, 2017
    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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