EEG NEUROAMP, MODEL CS10137

Device, Biofeedback

CORSCIENCE GMBH & CO. KG

The following data is part of a premarket notification filed by Corscience Gmbh & Co. Kg with the FDA for Eeg Neuroamp, Model Cs10137.

Pre-market Notification Details

Device IDK073557
510k NumberK073557
Device Name:EEG NEUROAMP, MODEL CS10137
ClassificationDevice, Biofeedback
Applicant CORSCIENCE GMBH & CO. KG HENKESTRASSE 91 Erlangen,  DE 91052
ContactChristine Baumann
CorrespondentChristine Baumann
CORSCIENCE GMBH & CO. KG HENKESTRASSE 91 Erlangen,  DE 91052
Product CodeHCC  
CFR Regulation Number882.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-19
Decision Date2008-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04251341900047 K073557 000
04251341900023 K073557 000
04251341900016 K073557 000

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