• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K183282, Biovitals Analytics Engine, by Biofourmis Singapore Pte., Ltd.

FDA 510(k) K183282, Biovitals Analytics Engine, by Biofourmis Singapore Pte., Ltd.

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510(K) Number: K183282
Device Name: Biovitals Analytics Engine
Manufacturer: Biofourmis Singapore Pte., Ltd.
Device Classification Name: Multivariate Vital Signs Index
Regulation Number: PLB
Classification Product Code: KXA
Date Received: 11/26/2018
Decision Date: 08/15/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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