• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K183319, Triangle System, by AliveCor, Inc.

FDA 510(k) K183319, Triangle System, by AliveCor, Inc.

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510(K) Number: K183319
Device Name: Triangle System
Manufacturer: AliveCor, Inc.
Device Classification Name: transmitters and receivers, electrocardiograph, telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 11/30/2018
Decision Date: 05/10/2019
Regulation Medical Specialty: Cardiovascular

Total pages: 1859
Fully redacted pages: 1534
Content pages: 325
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