Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K170441
    Device Name
    ElectroTek
    Manufacturer
    MobileMedTek
    Date Cleared
    2017-06-05

    (111 days)

    Product Code
    GWQ, GWO
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MobileMedTek

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient's brain obtained by placing electrodes on the patient scalp. The ElectroTek is intended to be used for such studies as electroencephelogram (EEG) and video EEG recording to aid in diagnosis. The ElectroTek does not draw any diagnostic conclusions.
    Device Description
    The ElectroTek is a portable EEG system designed to improve the overall EEG test experience for the patient, the electroneurodiagnostic technician running the EEG test, and the physician that reads the EEG results. The ElectroTek is optimized for fast setup with easy and intuitive use, resulting in improvements in overall usability at a lower total cost of ownership for an EEG system. The ElectroTek is designed to push data to the MobileMedTek Portal for secure archived data storage and remote viewing over the web by the reading physician. The ElectroTek's is used for routine EEG studies in outpatient clinic and small/medium hospital settings. The ElectroTek is also designed to be used in long term monitoring (LTM) conditions exceeding 24 hours per study. The ElectroTek EEG System is comprised of the case, device, custom hardware, the computing device, control software, firmware, peripheral devices, cables, and disposables. The peripheral devices include a Photic Stimulator for inducing seizure activity and a manually activated pushbutton Event Marker. Three primary Cables supplied by MobileMedTek as part of the ElectroTek include a Peripheral Cable that connects the Photic Stimulator to the ElectroTek Custom Hardware, the Event Marker cable that includes the handheld pushbutton and connects to the ElectroTek Custom Hardware, and a Patient Cable that includes a plug-in "yoke" box and connects to the ElectroTek Custom Hardware. Consumable Cables that will be supplied by MobileMedTek include four different electrode cables (the Sagittal (aka, "Midline") cable, the Parasagittal cable, the Transverse cable, and Individual cables. These cables are intended for re-use. The only single-use Disposables planned for the ElectroTek are the electrode cups that snap into the four consumable Cables and connect to the patient's head.
    Ask a Question

    Page 1 of 1