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

    Sapphire Infusion Pump, Sapphire administration sets

    K Number: K192860 · Decision Nov 19, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    844
    Applicant Total
    2
    Review Days
    412

    Basic Information

    Device Name
    Sapphire Infusion Pump, Sapphire administration sets
    K Number
    K192860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Q Core Medical Ltd.
    Date Received
    October 4, 2019
    Decision Date
    November 19, 2020
    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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    Other Clearances by Q Core Medical Ltd.

    K Number Device Name
    K161667 Sapphire Infusion Pump