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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 K141813
FOIA Releasable 510(k) K141813
Device Name RHYTHMSTAR SYSTEM
Applicant
RhythMedix, LLC
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Applicant Contact M.W.(ANDY) ANDERSON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2920
Classification Product Code
DXH  
Date Received07/07/2014
Decision Date 08/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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