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K Number
K001467
Device Name
DA VINCHI EMG/EP ISA1004EP
Manufacturer
AIRSEP CORP.
Date Cleared
2000-08-01

(83 days)

Product Code
GWE,GWF,GWJ
Regulation Number
882.1890
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1890 Evoked response photic stimulator.

(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).