BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Instrument, Glucose, Noninvasive Technology

    PMA: P990026 · Supplement: S021 · Decision Feb 25, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Instrument, Glucose, Noninvasive Technology
    Trade Name
    GLUCOWATCH G2 BIOGRAPHER
    PMA Number
    P990026
    Supplement Number
    S021
    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
    February 25, 2004
    Date Received
    October 1, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN EXPANSION OF THE LABELING TO INCLUDE A DESCRIPTION OF PRE-TREATMENT PRODUCTS AND A METHOD TO MINIMIZE THE AFFECTS OF SKIN IRRITATION WITHOUT AFFECTING THE ACCURACY OF G2 BIOGRAPHER GLUCOSE MEASUREMENTS.

    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