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K Number
K003644
Device Name
EYETECT TREMOR MONITOR UNIT (TMU)
Manufacturer
EYETECT, L.L.C.
Date Cleared
2001-02-01

(66 days)

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

§ 882.1460 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).