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

    SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP

    K Number: K941984 · Decision Jul 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    7
    Review Days
    85

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    Basic Information

    Device Name
    SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
    K Number
    K941984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sabratek Corp.
    Date Received
    April 25, 1994
    Decision Date
    July 19, 1994
    Product Code
    FRN
    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
    FRN Pump, Infusion

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