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510(k) Data Aggregation

    K Number
    K110752
    Device Name
    HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER
    Date Cleared
    2011-06-28

    (102 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    HIGHLAND INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Highland Instruments CES and TUS Instrument Holder is intended for use in assisting holding and securing commercially available CES electrodes and diagnostic Transcranial Ultrasound System Probes in the desired position on the patient's head.
    Device Description
    The Highland Instrument CES and TUS Instrument Holder is intended to position and hold in position the ultrasound probe of a Transcranial Ultrasound device while at the same time assisting in maintaining the position of electrodes used with a Cranial Electrotherapy Stimulator (CES) device and keeping the electrode lead wires free from entanglement and otherwise free from being disturbed by the patient. The Highland Instrument Holder allows for a physician to utilize a commercially available CES device while simultaneously observing/measuring cerebral regional blood flow in discreet areas of the brain. It further allows the physician to utilize a commercially available CES device while imaging the brain with transcranial ultrasound imaging probes that do not contain the Doppler option.
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