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510(k) Data Aggregation

    K Number
    K191258
    Device Name
    Intraosseous infusion device
    Date Cleared
    2019-10-23

    (166 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Einstein Works, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIO-P for pediatric is intended to provide Intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients in age 3-12 years of age.
    Device Description
    The Einstein Works NIO Pediatric (NIO- P) Intraosseous Infusion Device permits intraosseous access through the Proximal Tibia and the Humeral Head. The NIO device is comprised of a trocar needle, spring, piston and housing and it resembles a syringe. When activated, a loaded spring is released, and the device injects the needle to a predetermined depth into the bone marrow cavity. The NIO device also features the same safety latch and trigger mechanism which is found with the predicate device.
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