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K Number
K010059

Validate with FDA (Live)

Device Name
ENGPLUS
Manufacturer
WESTERN SYSTEMS RESEARCH, INC.
Date Cleared
2001-02-27

(50 days)

Product Code
GWN
Regulation Number
882.1460
Type
Traditional
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K070670
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.1460 Nystagmograph.

(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).