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

    ALCOHAWK PRECISION

    K Number: K043188 · Decision Feb 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    ALCOHAWK PRECISION
    K Number
    K043188
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3050
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Q3 Innovations, LLC
    Date Received
    November 17, 2004
    Decision Date
    February 9, 2005
    Product Code
    DJZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    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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