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510(k) Data Aggregation
K Number
K170441Device Name
ElectroTek
Manufacturer
MobileMedTek
Date Cleared
2017-06-05
(111 days)
Product Code
GWQ, GWO
Regulation Number
882.1400Why 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.
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