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510(k) Data Aggregation

    K Number
    K040228
    Device Name
    MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
    Manufacturer
    MEDI-STIM A/S
    Date Cleared
    2004-04-29

    (87 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-STIM A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-Stim VeriQ System is an intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. The clinical indications for the device are: - Accurate transit time blood volume and Doppler velocity flow measurements during cardiovascular-, vascular-, transplantation- and neuro-surgery. - Simultaneous measurements of blood pressure, vascular resistance, interfaced physiological signals and other derived parameters during these procedures. - Detection of normal and abnormal blood volume and Doppler velocity flow patterns during these procedures. - Provides guidance to prepare surgical plans at the initiation of surgery and to support the successful accomplishment of surgery including detection and location of vessels during surgical procedures. - Detection and quantification of the degree of stenosis in arteries by using the Doppler velocity profile.
    Device Description
    The Medi-Stim VeriQ System is used intraoperatively to measure blood volume and velocity waveforms in arteries and veins. Transit time and Doppler ultrasonography is used to obtain these measurements.
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    K Number
    K992305
    Device Name
    MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004
    Manufacturer
    MEDI-STIM A/S
    Date Cleared
    1999-09-08

    (62 days)

    Product Code
    ITX, DPT, DPW, DSK
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDI-STIM A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for accurate transit time blood volume flow measurements during cardiovascular, vascular and transplantation surgery.
    Device Description
    The Medi-Stim Butterfly Flowmeter estimates blood volume flow by measuring the transit time difference between an ultrasonic signal propagated through a blood vessel in the downstream direction and one propagated in the upstream direction. The measuring unit consists of two ultrasonic transducers on one side of the vessel aimed at a common point on a flat reflector on the other side of the vessel.
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