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

    BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP

    K Number: K802230 · Decision Dec 22, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    97

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    Basic Information

    Device Name
    BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP
    K Number
    K802230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cardio Med Supplies, Inc.
    Date Received
    September 16, 1980
    Decision Date
    December 22, 1980
    Product Code
    FIF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FIF Set, Dialysis, Single Needle With Uni-Directional Pump

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