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510(k) Data Aggregation
K Number
K123915Device Name
DE48-PLUS
Manufacturer
GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO
Date Cleared
2013-04-24
(126 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Grass "DE-48-Plus Disposable Electrodes" are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials.
Device Description
The Grass Technologies DE48-Plus Disposable Electrodes (various lengths) are noninvasive, cutaneous devices, applied directly to the skin, and used in the acquisition of physiological signals for the purpose of montoring and recording Electroencephalograph (EEG), PSG and similar physiological parameters.
Non-invasive, disposable surface electrode discs (Cutaneous Electrodes), as included in this submission, are applied to the skin using a cream or gel for adhesion. Their purpose is to pick up and transfer microvoltage signals, as generated by the body, to recording equipment, for the purpose of monitoring and recording associated with electroencephalography and electromyography. The new Grass DE-48-Plus electrodes, as with the BNT predicate, are manufactured with a circular, raised cup body molded from ABS plastic and coated with silver chloride (Ag/AgCl). The disc is adhered to a lead wire which is covered with heat shrink tubing and terminates with a molded connector that conforms to DIN 42-802 for electrical safety. Grass DE-48-Plus Electrodes connect to, and work with, any EEG equipment, without special attachments.
The DE-48-Plus electrodes are made up of the following materials (same or equivalent to the Rhythmlink predicate).
Cup Disk: ABS Plastic with an Aq/AqCl coating which is nominally measured at 10mm (8.5 to 10mm).
The connecting wire which is manufactured from 28AWG stranded Tin Copper conductor with soft PVC insulation.
Wire crimped to Cup Electrode using Tin plated copper tubing.
Terminal connected with Alex crimp type, 24-30AWG Brass, Tin plated, Molded in Palprene.
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