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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K181502
Device Name Zio AT ECG Monitoring System, ZEUS System
Applicant
Irhythm Technologies, Inc.
650 Townsend St., Suite 500
San Francisco,  CA  94103
Applicant Contact Rich Laguna
Correspondent
Irhythm Technologies, Inc.
650 Townsend St., Suite 500
San Francisco,  CA  94103
Correspondent Contact Rich Laguna
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/07/2018
Decision Date 08/29/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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