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K Number
K000963
Device Name
DA VINCHI EEG AND EMG/EP SYSTEMS
Manufacturer
AIRSEP CORP.
Date Cleared
2000-10-20

(210 days)

Product Code
GWF,GWE,GWJ,GWQ,IKN,JXE,OLT
Regulation Number
882.1870
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).