MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)

Electrode, Cortical

NIHON KOHDEN CORP.

The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Ms-120bk Electric Stimulator (extension Unit).

Pre-market Notification Details

Device IDK110410
510k NumberK110410
Device Name:MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
ClassificationElectrode, Cortical
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 CodeGYC  
CFR Regulation Number882.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-14
Decision Date2011-08-04
Summary:summary

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