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

    ON-Q* Pump with Bolus

    K Number: K181360 · Decision Mar 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    304

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    Basic Information

    Device Name
    ON-Q* Pump with Bolus
    K Number
    K181360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Halyard Health
    Date Received
    May 22, 2018
    Decision Date
    March 22, 2019
    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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