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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 K190593
Device Name Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Applicant
iRhythm Technologies, Inc.
650 Townsend Street, Ste 500
San Francisco,  CA  94103
Applicant Contact Gabrielle Logan
Correspondent
iRhythm Technologies, Inc.
650 Townsend Street, Ste 500
San Francisco,  CA  94103
Correspondent Contact Gabrielle Logan
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/07/2019
Decision Date 08/23/2019
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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