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

    PRODIGY

    K Number: K053593 · Decision Jul 6, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    4
    Review Days
    195

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    Basic Information

    Device Name
    PRODIGY
    K Number
    K053593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diagnostic Devices, Inc.
    Date Received
    December 23, 2005
    Decision Date
    July 6, 2006
    Product Code
    NBW
    Advisory Committee
    Clinical Chemistry
    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
    NBW System, Test, Blood Glucose, Over The Counter

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    Other Clearances by Diagnostic Devices, Inc.

    K Number Device Name
    K090307 DDI ULTRASONIC NEBULIZER SYSTEM
    K073118 PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
    K060467 PRODIGY BLOOD GLUCOSE TEST SYSTEM