K Number
K101386Device Name
VIGILANT EEG MONITOR MODEL VIGILANT 2.0Manufacturer
Date Cleared
2010-07-30
(73 days)
Product Code
Regulation Number
882.1400Type
SpecialPanel
NEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).