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K Number
K002734
Device Name
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
Manufacturer
ASPECT MEDICAL SYSTEMS, INC.
Date Cleared
2000-09-14

(13 days)

Product Code
GXY
Regulation Number
882.1320
Type
Special
Panel
Neurology
Reference & Predicate Devices
N/A
Predicate For
K041670,K050313,K062692,K091854,K093183
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).