BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

    PMA: P810044 · Supplement: S005 · Decision Apr 8, 2005
    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
    DIABETES SENTRY
    PMA Number
    P810044
    Supplement Number
    S005
    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
    April 8, 2005
    Date Received
    February 28, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE CHANGE OF THE DEVICE WEB ADDRESS, AND A CHANGE TO THE NAME OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIABETES SENTRY.

    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