PE-210AK SWITCH BOX

Full-montage Standard Electroencephalograph

NIHON KOHDEN CORP.

The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Pe-210ak Switch Box.

Pre-market Notification Details

Device IDK110376
510k NumberK110376
Device Name:PE-210AK SWITCH BOX
ClassificationFull-montage Standard Electroencephalograph
Applicant NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch,  CA  92610
ContactSteve Geerdes
CorrespondentSteve Geerdes
NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch,  CA  92610
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-09
Decision Date2011-07-29
Summary:summary

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