K Number
K964644Device Name
AD-TECH'S DEPTH ELECTRODEManufacturer
Date Cleared
1997-05-09
(190 days)
Product Code
Regulation Number
882.1330Type
TraditionalPanel
NEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).