BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    QiF Blood and Fluid Warmer

    K Number: K171215 · Decision Sep 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    74
    Applicant Total
    5
    Review Days
    155

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    Basic Information

    Device Name
    QiF Blood and Fluid Warmer
    K Number
    K171215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quality IN Flow , Ltd.
    Date Received
    April 25, 2017
    Decision Date
    September 27, 2017
    Product Code
    LGZ
    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
    LGZ Warmer, Thermal, Infusion Fluid

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    Other Clearances by Quality IN Flow , Ltd.

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