FDA 510(k), K183319, Triangle System

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