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K Number
K960097

Validate with FDA (Live)

Device Name
CHARTR EP
Manufacturer
ICS MEDICAL CORP.
Date Cleared
1997-02-21

(407 days)

Product Code
GWJ
Regulation Number
882.1900
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K083399
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.1900 Evoked response auditory stimulator.

(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).