K Number
K071697Device Name
NEURONAV SYSTEM AND NEURONAV DRIVEManufacturer
Date Cleared
2007-12-03
(166 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).