NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

Stimulator, Electrical, Evoked Response

NEXSTIM OY

The following data is part of a premarket notification filed by Nexstim Oy with the FDA for Nexstim Navigated Brain Stimulation (nbs) System 4, Nexstim Nbs System 4 With Nexspeech(tm).

Pre-market Notification Details

Device IDK112881
510k NumberK112881
Device Name:NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
ClassificationStimulator, Electrical, Evoked Response
Applicant NEXSTIM OY ELIMAENKATU 9 B Helsinki,  FI Fi-00510
ContactRainer Harjunpaa
CorrespondentRainer Harjunpaa
NEXSTIM OY ELIMAENKATU 9 B Helsinki,  FI Fi-00510
Product CodeGWF  
Subsequent Product CodeHAW
Subsequent Product CodeIKN
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-30
Decision Date2012-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06430063200125 K112881 000
06430063200118 K112881 000
06430063200095 K112881 000
06430063200088 K112881 000
06430063200064 K112881 000
06430063200057 K112881 000
06430063200033 K112881 000
06430063200026 K112881 000
06430063200002 K112881 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.