ELECTRODE JUNCTION BOX, MODEL JE-921A

Standard Polysomnograph With Electroencephalograph

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Electrode Junction Box, Model Je-921a.

Pre-market Notification Details

Device IDK050833
510k NumberK050833
Device Name:ELECTRODE JUNCTION BOX, MODEL JE-921A
ClassificationStandard Polysomnograph With Electroencephalograph
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
ContactSerrah Namini
CorrespondentSerrah Namini
NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
Product CodeOLV  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-01
Decision Date2005-04-29
Summary:summary

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