EEG & RESPIRATION MODULES POLYGRAPH

Monitor, Breathing Frequency

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Eeg & Respiration Modules Polygraph.

Pre-market Notification Details

Device IDK823563
510k NumberK823563
Device Name:EEG & RESPIRATION MODULES POLYGRAPH
ClassificationMonitor, Breathing Frequency
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
Product CodeBZQ  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-02
Decision Date1983-01-12

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