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K Number
K010019

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Device Name
STERILE SUBDERMAL NEEDLE ELECTRODES
Manufacturer
NICOLET BIOMEDICAL, INC.
Date Cleared
2001-03-19

(76 days)

Product Code
GXZ
Regulation Number
882.1350
Type
Abbreviated
Panel
Neurology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K022914,K040639,K050194
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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).