• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K142024, BRIGHTMATTER NAVIGATION SYSTEM, by Synaptive Medical, Inc.

FDA 510(k) K142024, BRIGHTMATTER NAVIGATION SYSTEM, by Synaptive Medical, Inc.

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510(K) Number: K142024
Device Name: BRIGHTMATTER NAVIGATION SYSTEM
Manufacturer: Synaptive Medical, Inc.
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 07/25/2014
Decision Date: 04/02/2015
Regulation Medical Specialty: Neurology
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