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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 K123255
Device Name g.HIamp
Applicant
G.TEC MEDICAL ENGINEERING GMBH
SIERNINGSTRASSE 14
SCHIEDLBERG,  AT 4521
Applicant Contact CHRISTOPH GUGER
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Regulation Number882.1835
Classification Product Code
GWL  
Date Received10/18/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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