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K Number
K955597
Device Name
MEDI-TRACE DEFIB PADS
Manufacturer
GRAPHIC CONTROLS CORP.
Date Cleared
1996-07-09

(214 days)

Product Code
GYB
Regulation Number
882.1275
Type
Traditional
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
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).