BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS

    K Number: K060761 · Decision Apr 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    38

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    Basic Information

    Device Name
    BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
    K Number
    K060761
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3050
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Akers Biosciences, Inc.
    Date Received
    March 21, 2006
    Decision Date
    April 28, 2006
    Product Code
    DJZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DJZ Devices, Breath Trapping, Alcohol

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