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

    DANA

    K Number: K141865 · Decision Oct 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    97

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    Basic Information

    Device Name
    DANA
    K Number
    K141865
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anthrotronix, Inc.
    Date Received
    July 10, 2014
    Decision Date
    October 15, 2014
    Product Code
    LQD
    Advisory Committee
    Unknown
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQD Recorder, Attention Task Performance

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