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    K Number
    K172209
    Device Name
    AURA ICP MONITORING SYSTEM
    Manufacturer
    Branchpoint Technologies, INC.
    Date Cleared
    2018-05-18

    (298 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Branchpoint Technologies, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.
    Device Description
    The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages: Package 1) AURA™ Sensor Tray (Model SP101-A) - AURA™ Sensor (Model 10025G) - Disposable Scalp Retractor (Model OS0001B) - Disposable Drill Bit with Collar (Model 10008C) - Disposable Torque Wrench (Model OS0004C) - Disposable Antenna Holster (Model 10007A) Package 2) AURA™ Monitor Pack (Model TK101-A) - AURA™ Monitor (Model T0011B) - AURA™ Antenna (Model T0010A) - 2x Lithium-Ion 11v Rechargeable Batteries (Model T0032A) - Two-bay battery charger (Model T0014A) Package 3) AURA™ Data Receiver Pack (Model DG101-A) - AURA™ Data Receiver (Model D0004B)
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