BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Instrument, Glucose, Noninvasive Technology

    PMA: P990026 · Supplement: S018 · Decision Nov 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Instrument, Glucose, Noninvasive Technology
    Trade Name
    GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR
    PMA Number
    P990026
    Supplement Number
    S018
    Device Class
    FDA Class 3
    Product Code
    NCT
    Generic Name
    INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 20, 2003
    Date Received
    July 1, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE SIGNAL PROCESSING ROUTINE AND DATA POINT SCREENING PARAMETERS OF THE BIOGRAPHER TO REDUCE THE NUMBER OF SKIPPED READINGS, MODIFICATIONS TO THE DOWN ALERT OF THE BIOGRAPHER TO INCREASE THE SPECIFICITY OF THE ALARM FEATURE AND AN AUTOSENSOR FORMULATION CHANGE TO IMPROVE THE BIOGRAPHER CALIBRATION.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NCT Instrument, Glucose, Noninvasive Technology