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K Number
K964737

Validate with FDA (Live)

Device Name
HYDROPREP GEL
Manufacturer
D.O. WEAVER CO.
Date Cleared
1997-03-19

(114 days)

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