BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

    PMA: P810044 · Supplement: S004 · Decision Jun 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions
    Trade Name
    SLEEP SENTRY
    PMA Number
    P810044
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    LMY
    Generic Name
    Monitor, skin resistance/skin temperature, for insulin reactions
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 12, 2003
    Date Received
    April 30, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PHYSICAL DESIGN AND LAYOUT OF THE DEVICE, DEVICE LABELING, AND MANUFACTURING FACILITIES AND PROCESSES. THE MANUFACTURING SITES ARE LOCATED AT DIABETES SENTRY PRODUCTS, INC. (DSP), BELLINGHAM WASHINGTON AND DATREND SYSTEMS, INC., RICHMOND, BC CANADA.

    Classifications

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

    Product Code Device Name
    LMY Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions