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K Number
K970587
Device Name
AD-TECH SUBDURAL ELECTRODE
Manufacturer
AD-TECH MEDICAL INSTRUMENT CORP.
Date Cleared
1997-05-09

(80 days)

Product Code
GYC
Regulation Number
882.1310
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1310 Cortical electrode.

(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).