K Number
K010019Device Name
STERILE SUBDERMAL NEEDLE ELECTRODESManufacturer
Date Cleared
2001-03-19
(76 days)
Product Code
Regulation Number
882.1350Type
AbbreviatedPanel
NEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).