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K Number
K003442
Device Name
MODIFICATION TO EDI VERIS SYSTEM
Manufacturer
ELECTRO-DIAGNOSTIC IMAGING, INC.
Date Cleared
2001-05-04

(179 days)

Product Code
HLX
Regulation Number
886.1630
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 886.1630 AC-powered photostimulator.

(a)
Identification. An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).(b)
Classification. Class II.