Switch Box for the EEG
NA - PE-210AK
Device Description
An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GWQ
Device Name: Full-Montage Standard Electroencephalograph
Device Class: 2
Physical State: May include standard electroencephalograph recording hardware (e.g. headbox, cables, computer, monitor, wireless) and basic software (e.g. used to display, store, archive, or manually annotate data). Does NOT include electrodes, more complex software used to analyze electroencephalograph data or automatically detect events, electroencephalograph used for polysomnography or sleep studies, or electroencephalograph with less than 16 electrodes.
Definition: Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Uses electrodes (16 or more) placed on the scalp or within the brain, via user-specified locations, to record and display electrical activity of the brain
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Brain
Regulation Number: 882.1400
Third Party Flag: Y
Medical Specialty: NE
Code: GYC
Device Name: Electrode, Cortical
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 882.1310
Third Party Flag: Y
Medical Specialty: NE
Device IdentifiersDevice Id: 00841983101076
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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