FDA 510(k) Application Details - K150462

Device Classification Name System, Optical Position/Movement Recording

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510(K) Number K150462
Device Name System, Optical Position/Movement Recording
Applicant Reflexion Health, Inc.
223 Broadway, Suite 650
San Diego, CA 92130 US
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Contact Huan Tran
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Regulation Number 000.0000

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Classification Product Code LXJ
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Date Received 02/23/2015
Decision Date 10/30/2015
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



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