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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K081471
Device Name ECARD AND CCARD
Applicant
iRhythm Technologies, Inc.
650 Townsend St., Suite 380
San Francisco,  CA  94103
Applicant Contact WILLIAM H RIGHTER
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/27/2008
Decision Date 06/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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