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    K Number
    K071231
    Device Name
    EDAC QUANTIFIER
    Manufacturer
    LUNA INNOVATIONS, INC.
    Date Cleared
    2007-05-17

    (14 days)

    Product Code
    KRL
    Regulation Number
    870.4205
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUNA INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EDAC™ QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.
    Device Description
    The EDAC™ QUANTIFIER is a standalone system in which the ultrasonic sensing system consists of a three-channel ultrasonic pulser-receiver unit, a touchpanel computer, ultrasound transducers and clamps for attached the transducers to the circuit. This system is currently being certified according to voluntary medical device safety standards UL 60601-1 . IEC 60601-1-2 and IEC 60601-1-4, covering electrical device safety in medical products and IEC-60601-2-37, covering ultrasonic diagnostic safety. It also employs software and firmware to provide the embedded signal processing needed to detect gas emboli over the range of sizes described.
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