FDA 510(k), K190593, Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

510(K) Number: K190593
Device Name: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Manufacturer: iRhythm Technologies, Inc.
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 03/07/2019
Decision Date: 08/23/2019
Regulation Medical Specialty: Cardiovascular

332 pages (2,967 of 3,299 original pages are fully redacted)