NeuroAmp II, NeuroAmp II.5s

Full-montage Standard Electroencephalograph

Corscience GmbH & Co. KG

The following data is part of a premarket notification filed by Corscience Gmbh & Co. Kg with the FDA for Neuroamp Ii, Neuroamp Ii.5s.

Pre-market Notification Details

Device IDK193159
510k NumberK193159
Device Name:NeuroAmp II, NeuroAmp II.5s
ClassificationFull-montage Standard Electroencephalograph
Applicant Corscience GmbH & Co. KG Hartmannstrasse 65 Erlangen,  DE 91052
ContactStefan Bolleininger
CorrespondentStefan Bolleininger
Corscience GmbH & Co. KG Hartmannstrasse 65 Erlangen,  DE 91052
Product CodeGWQ  
Subsequent Product CodeGWE
Subsequent Product CodeGWJ
Subsequent Product CodeHCC
Subsequent Product CodeOLV
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-15
Decision Date2020-12-30

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.