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

    INFUSION PUMP

    K Number: K882830 · Decision Dec 30, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    175

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    Basic Information

    Device Name
    INFUSION PUMP
    K Number
    K882830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pemlab Corp.
    Date Received
    July 8, 1988
    Decision Date
    December 30, 1988
    Product Code
    LZF
    Advisory Committee
    General Hospital
    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
    LZF Pump, Infusion, Analytical Sampling

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