BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Controller, Closed-Loop Blood Glucose

    PMA: P790028 · Supplement: S002 · Decision Aug 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Controller, Closed-Loop Blood Glucose
    Trade Name
    BIOSTATOR GCIIS
    PMA Number
    P790028
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    LHE
    Generic Name
    Controller, closed-loop blood glucose
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 8, 1983
    Date Received
    April 21, 1983
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LHE Controller, Closed-Loop Blood Glucose