BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Instrument, Glucose, Noninvasive Technology

    PMA: P990026 · Supplement: S020 · Decision Aug 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Instrument, Glucose, Noninvasive Technology
    Trade Name
    GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
    PMA Number
    P990026
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    NCT
    Generic Name
    INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 20, 2003
    Date Received
    August 1, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE MANUFACTURING PROCESS OF THE GLUCOWATCH BIOGRAPHER AUTOSENSOR TO ADD A SECONDARY VISUAL INSPECTION OF THE AUTOSENSORS REJECTED BY THE AUTOMATED, CAMERA-BASED INSPECTION TO INCREASE PRODUCT YIELD AND REDUCE PRODUCTION COSTS.

    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