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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 K060803
Device Name G.USBAMP
Applicant
G.Tec Medical Engineering GmbH
Sierningstrasse14
Schiedlberg,  AT 4521
Applicant Contact CHRISTOPH GUGER
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact STEFAN PREISS
Regulation Number882.1835
Classification Product Code
GWL  
Date Received03/24/2006
Decision Date 05/02/2006
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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