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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 K252859
Device Name ZEUS Platform (FG0501US)
Applicant
iRhythm Technologies, Inc.
699 8th St.
Suite 600
San Francisco,  CA  94103
Applicant Contact Brittany Davis
Correspondent
iRhythm Technologies, Inc.
699 8th St.
Suite 600
San Francisco,  CA  94103
Correspondent Contact Brittany Davis
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/09/2025
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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