FDA 510(k) Application Details - K031930

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K031930
Device Name Stimulator, Electrical, Evoked Response
Applicant MEDICAL MEASUREMENT SYSTEMS,B.V.
COLOSSEUM 25
ENSCHEDE 7521 PV NL
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Contact KARIN OGINK-SOMHORST
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 06/23/2003
Decision Date 03/03/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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