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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 K170506
Device Name ECG Check - Universal, ECG Check - Universal Plus
Applicant
Cardiac Designs, Inc.
25510 Interstate 45 N
Suite 202
Spring,  TX  77386
Applicant Contact James Tassone
Correspondent
Cjp Consulting, Inc.
5831 N Kostner Ave.
Chicago,  IL  60646
Correspondent Contact Cynthia J. Pillar
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/21/2017
Decision Date 10/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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