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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 K142681
Device Name ZEUS (ZIO ECG Utilization Service) 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 Number870.1425
Classification Product Code
DQK  
Date Received09/19/2014
Decision Date 11/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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