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K Number
K001705

Validate with FDA (Live)

Device Name
STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
Manufacturer
CHESTER LABS, INC.
Date Cleared
2000-06-29

(24 days)

Product Code
GYB
Regulation Number
882.1275
Type
Special
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K013623
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.1275 Electroconductive media.

(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).