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

    SIMPLEABI

    K Number: K110628 · Decision May 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    SIMPLEABI
    K Number
    K110628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Newman Medical
    Date Received
    March 3, 2011
    Decision Date
    May 12, 2011
    Product Code
    JAF
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    JAF Monitor, Ultrasonic, Nonfetal

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