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K Number
K011534

Validate with FDA (Live)

Device Name
EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
Manufacturer
ASPECT MEDICAL SYSTEMS, INC.
Date Cleared
2001-06-15

(28 days)

Product Code
OLW,OLT,OMC,ORT
Regulation Number
882.1400
Type
Special
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K013389,K030267,K031694
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).