EMG MODULES FOR POLYGRAPH SYSTEM

Electromyograph, Diagnostic

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Emg Modules For Polygraph System.

Pre-market Notification Details

Device IDK823562
510k NumberK823562
Device Name:EMG MODULES FOR POLYGRAPH SYSTEM
ClassificationElectromyograph, Diagnostic
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
Product CodeIKN  
CFR Regulation Number890.1375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-02
Decision Date1983-01-14

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