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510(k) Data Aggregation
K Number
K063797Device Name
GEODESIC EEG SYSTEM 300
Manufacturer
ELECTRICAL GEODESICS, INCORPORATED
Date Cleared
2007-01-25
(34 days)
Product Code
OLT, GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
ELECTRICAL GEODESICS, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geodesic EEG System™ 300 (GES 300) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
Device Description
The Geodesic EEG System™ 300 (GES 300) is a digital electroencephalograph system (EEG) with dedicated electrodes. It consists of an amplifier, computer, software . Geodesic Sensor Net® (electrodes), and additional components such as cables. Modifications which constitute the GES 300 include a compact amplifier, software upgrade, additional display modes and tools, and options for computer configuration.
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K Number
K043309Device Name
GEODESIC PHOTOGRAMMETRY SYSTEM
Manufacturer
ELECTRICAL GEODESICS, INCORPORATED
Date Cleared
2005-01-26
(56 days)
Product Code
GWQ, GWO, KOM
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
ELECTRICAL GEODESICS, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geodesic Photogrammetry System is intended for use in recording precise locations of EEG electrodes in the Geodesic Sensor Net on a patient's head.
Device Description
The GPS consists of a geodesic dome structure containing 11 mounted cameras, a steel supporting structure, a dedicated computer, and accompanying software. It is used with a Geodesic Sensor Net and any EGI Geodesic EEG system. It allows the user to record the locations of the dense array EEG electrodes on a patient's head. No part of the Geodesic Photogrammetry System touches the patient.
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K Number
K033399Device Name
GEODESIC EEG SYSTEM SERIES 100
Manufacturer
ELECTRICAL GEODESICS, INCORPORATED
Date Cleared
2004-08-04
(285 days)
Product Code
GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
ELECTRICAL GEODESICS, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geodesic EEG System™ Series 100 products are intended to measure and record The Clectrical activity of the patient's brain. They can be used on adults, children, and infants.
Device Description
The Geodesic EEG System™ Series 100 products, also known as the GES Series 100, are digital electroencephalography systems (EEG) that can accommodate up to 256 electrodes. The GES Series 100 is computer controlled and capable of acquiring, storing, and displaying data. It includes electrodes, amplifiers, a central processing unit, and software. The GES Series 100 uses some components from the previously submitted and cleared Geodesic EEG System™ Model 200. It blends these with components from another manufacturer. The combined product is new and has not been previously submitted to FDA.
The GES Series 100 products are composed of the following components. The Geodesic Sensor Net® is a dense array of scalp electrodes designed to allow rapid application in an even distribution across the head and is the preferred electrode system. Standard EEG electrodes and cap-type electrodes purchased from other vendors may also be used. The Neurotravel WIDE consists of multiple amplifiers for physiological signals that are fully software controlled. The central processing unit can be either Mac based or PC based. Mac based systems use the proprietary Net Station® software package to control acquisition of data, storage of digital data, and manipulation of data for review. PC based systems use the Neurotravel Win software package to control similar system features. Neither software package performs any diagnosis. Additional components of the system are an articulated arm with extended cable, isolation transformer, rack system, various cables, standard components of personal computer (monitor, keyboard, and mouse), photic stimulator, video EEG, electrolyte solution, and disinfectant.
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K Number
K012079Device Name
GEODESIC EEG SYSTEM, MODEL 200
Manufacturer
ELECTRICAL GEODESICS, INCORPORATED
Date Cleared
2001-09-19
(78 days)
Product Code
GWQ
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
ELECTRICAL GEODESICS, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Geodesic EEG System is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
Device Description
The Geodesic EEG System is a digital electroencephalography system (EEG) with a dense sensor array of 32 to 256 channels. Like existing digital EEG systems, the Geodesic EEG System is computer controlled and capable of acquiring, storing, and displaying data. It includes scalp conductive electrodes, amplifiers, a central processing unit, and software. The Geodesic Sensor Net is a dense array of scalp electrodes designed to allow rapid application in an even distribution across the head. The Net Amps " consists of multiple amplifiers for physiological signals that are fully software controlled. Net Station® is the software package that provides control of the Geodesic EEG System, digital data storage, and operator-selected waveform displays. The software does not perform any data analysis. Additional components of the system are an articulated arm with extended cable, rack system, various cables, standard components of personal computer (monitor, keyboard, mouse), electrolyte solution, and disinfectant.
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