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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 K091075
Device Name ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
Applicant
IRHYTHM TECHNOLOGIES, INC.
650 TOWNSEND STREET
SUITE 380
SAN FRANCISCO,  CA  94103
Applicant Contact MICHAEL RIGHTER
Correspondent
IRHYTHM TECHNOLOGIES, INC.
650 TOWNSEND STREET
SUITE 380
SAN FRANCISCO,  CA  94103
Correspondent Contact MICHAEL RIGHTER
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/14/2009
Decision Date 07/21/2009
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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