NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES

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 Nihon Kohden Meb-2200a Neuropack Evoked Potential & Emg Measuring System With Accessories.

Pre-market Notification Details

Device IDK991899
510k NumberK991899
Device Name:NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
ClassificationStimulator, Electrical, Evoked Response
Applicant NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
ContactBonnie Bishop
CorrespondentBonnie Bishop
NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine,  CA  92612 -1601
Product CodeGWF  
Subsequent Product CodeGWQ
Subsequent Product CodeGZO
Subsequent Product CodeIKN
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-04
Decision Date1999-09-01
Summary:summary

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