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

    PACER MODEL 100 INFUSION CONTROLLER

    K Number: K963136 · Decision Oct 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    423

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    Basic Information

    Device Name
    PACER MODEL 100 INFUSION CONTROLLER
    K Number
    K963136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Health Watch, Inc.
    Date Received
    August 13, 1996
    Decision Date
    October 10, 1997
    Product Code
    LDR
    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
    LDR Controller, Infusion, Intravascular, Electronic

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