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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amplifier, physiological signal
510(k) Number K171669
Device Name g.Nautilus PRO
Applicant
g.tec medical engineering GmbH
Sierningstrasse14
Schiedlberg,  AT 4521
Applicant Contact Christoph Guger
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact Alexander Schapovalov
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
GXY  
Date Received06/05/2017
Decision Date 07/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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