FDA 510(k) Application Details - K143034

Device Classification Name System, Optical Position/Movement Recording

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510(K) Number K143034
Device Name System, Optical Position/Movement Recording
Applicant JINTRONIX INC.
999 3rd Ave, Suite 3400
Seattle, WA 98104 US
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Contact Mark Evin
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Regulation Number 000.0000

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Classification Product Code LXJ
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Date Received 10/22/2014
Decision Date 04/22/2015
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

FDA Source Information for K143034


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