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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K180234
Device Name physiQ Heart Rhythm Module
Applicant
Physiq, Inc.
300 E. 5th Ave., Suite 105
Naperville,  IL  60563
Applicant Contact George Allen Hides
Correspondent
Physiq, Inc.
300 E. 5th Ave., Suite 105
Naperville,  IL  60563
Correspondent Contact George Allen Hides
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/29/2018
Decision Date 08/10/2018
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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