FDA 510(k) Application Details - K060374

Device Classification Name Amplifier, Physiological Signal

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510(K) Number K060374
Device Name Amplifier, Physiological Signal
Applicant TMS INTERNATIONAL BV
7744 SWAPS TRAIL
EVERGREEN, CO 80439 US
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Contact DAVID W WAGNER
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Regulation Number 882.1835

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Classification Product Code GWL
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Date Received 02/13/2006
Decision Date 05/30/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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