FDA 510(k) Application Details - K171547

Device Classification Name System, Optical Position/Movement Recording

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510(K) Number K171547
Device Name System, Optical Position/Movement Recording
Applicant Qualisys AB
Kvarnbergsgatan 2
Goteborg 411 05 SE
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Contact Henrik Wiberg
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Regulation Number 000.0000

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Classification Product Code LXJ
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Date Received 05/26/2017
Decision Date 08/02/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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