COGNITRACE

Full-montage Standard Electroencephalograph

EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Cognitrace.

Pre-market Notification Details

Device IDK051825
510k NumberK051825
Device Name:COGNITRACE
ClassificationFull-montage Standard Electroencephalograph
Applicant EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH PO BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH PO BOX 7007 Deerfield,  IL  60015
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-05
Decision Date2005-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B195SC100 K051825 000
B195LE200 K051825 000
B195LC107 K051825 000
B195LC106 K051825 000
B195LC105 K051825 000
B195LC104 K051825 000
B195ES220 K051825 000
B195LC100 K051825 000

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