SEN-4100 ELECTRIC STIMULATOR

Stimulator, Electrical, Evoked Response

NIHON KOHDEN AMERICA, INC.

The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Sen-4100 Electric Stimulator.

Pre-market Notification Details

Device IDK071969
510k NumberK071969
Device Name:SEN-4100 ELECTRIC STIMULATOR
ClassificationStimulator, Electrical, Evoked Response
Applicant NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
ContactJack Coggan
CorrespondentJack Coggan
NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch,  CA  92610 -1601
Product CodeGWF  
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-17
Decision Date2008-10-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04931921887981 K071969 000
04931921105313 K071969 000
00841983102318 K071969 000
00841983101427 K071969 000

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