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K Number
K010590
Device Name
NEUROPACK MICRO, MODEL MED-9100A SERIES
Manufacturer
NIHON KOHDEN AMERICA, INC.
Date Cleared
2001-06-28

(121 days)

Product Code
IKN,GWE,GWF,GWJ,GWQ,GZO,JXE
Regulation Number
890.1375
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).