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K Number
K003154
Device Name
MIZAR, BASIS BE, SANDMAN DIGITAL
Manufacturer
EB NEURO, S.P.A.
Date Cleared
2001-01-05

(87 days)

Product Code
GWL
Regulation Number
882.1835
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1835 Physiological signal amplifier.

(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).