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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
Cardiac Designs, Inc.
25510 Interstate 45 N
Suite 202
spring,  TX  77386
Applicant Contact james tassone
CJP Consulting, Inc.
5831 N Kostner Ave
chigaco,  IL  60646
Correspondent Contact cynthia j. pillar
Regulation Number870.2920
Classification Product Code
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