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K Number
K944599
Device Name
GRAHAM-FIELD CONDUCTIVE ECG SPRAY
Manufacturer
CHESTER LABS, INC.
Date Cleared
1996-05-07

(596 days)

Product Code
GYB
Regulation Number
882.1275
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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).