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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name detector and alarm, arrhythmia
510(k) Number K163512
Device Name Zio AT ECG Monitoring System
Applicant
IRHYTHM TECHNOLOGIES, INC.
650 TOWNSEND STREET
SUITE 380
san francisco,  CA  94103
Applicant Contact rich laguna
Correspondent
IRHYTHM TECHNOLOGIES, INC.
650 TOWNSEND STREET
SUITE 380
san francisco,  CA  94103
Correspondent Contact rich laguna
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Codes
DQK   DSH   DXH  
Date Received12/15/2016
Decision Date 06/02/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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