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

    BREATHSCN PRO

    K Number: K102338 · Decision Jan 12, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    147

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    Basic Information

    Device Name
    BREATHSCN PRO
    K Number
    K102338
    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
    August 18, 2010
    Decision Date
    January 12, 2011
    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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