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K Number
K030517
Device Name
BALL RECORDING ELECTRODE/STIMULATION PROBE
Manufacturer
VIASYS HEALTHCARE, INC.
Date Cleared
2003-08-01

(163 days)

Product Code
GZK
Regulation Number
882.1340
Type
Abbreviated
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 882.1340 Nasopharyngeal electrode.

(a)
Identification. A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.(b)
Classification. Class II (performance standards).