BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIACARE MONITORING SYSTEM

    K Number: K882001 · Decision Oct 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    159

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    Basic Information

    Device Name
    DIACARE MONITORING SYSTEM
    K Number
    K882001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Healthware Corp.
    Date Received
    May 12, 1988
    Decision Date
    October 18, 1988
    Product Code
    NDC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NDC Calculator, Drug Dose

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