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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 K063599
Device Name PORTI 7 PHYSIOLOGICAL AMPLIFIER
Applicant
TMS INTERNATIONAL BV
7744 SWAPS TRAIL
EVERGREEN,  CO  80439
Applicant Contact DAVID W WAGNER
Correspondent
TMS INTERNATIONAL BV
7744 SWAPS TRAIL
EVERGREEN,  CO  80439
Correspondent Contact DAVID W WAGNER
Regulation Number882.1835
Classification Product Code
GWL  
Date Received12/04/2006
Decision Date 03/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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