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

    MCKINLEY SP DISPOSABLE INFUSION PUMP

    K Number: K990461 · Decision Jun 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    138

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    Basic Information

    Device Name
    MCKINLEY SP DISPOSABLE INFUSION PUMP
    K Number
    K990461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mckinley, Inc.
    Date Received
    February 12, 1999
    Decision Date
    June 30, 1999
    Product Code
    MEB
    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
    MEB Pump, Infusion, Elastomeric

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    Other Clearances by Mckinley, Inc.

    K Number Device Name
    K042228 BEELINE MOTIV, PROPOLIS, PCA
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    K032642 BEELINE SYSTEM
    K991275 WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
    K982256 OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
    K971844 MCKINLEY OUTBOUND-2 SYSTEM