FDA 510(k) Application Details - K163245

Device Classification Name System, Optical Position/Movement Recording

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510(K) Number K163245
Device Name System, Optical Position/Movement Recording
Applicant Barron Associates, Inc.
1410 Sachem Place
Suite 202
Charlottesville, VA 22901 US
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Contact Bruce G. Wilson
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Regulation Number 000.0000

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Classification Product Code LXJ
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Date Received 11/18/2016
Decision Date 02/28/2017
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 K163245


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