FDA 510(k) Application Details - K162748

Device Classification Name System, Optical Position/Movement Recording

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510(K) Number K162748
Device Name System, Optical Position/Movement Recording
Applicant MindMaze SA
Chemin de Roseneck 5
Lausanne CH-1006 CH
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Contact SYLVAIN BOURRIQUET
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Regulation Number 000.0000

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Classification Product Code LXJ
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Date Received 09/30/2016
Decision Date 04/24/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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