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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 K183322
Device Name physIQ Heart Rhythm and Respiratory Module
Applicant
physIQ, Inc
300 E. 5th Avenue, Suite 105
naperville,  IL  60563
Applicant Contact george allen hides
Correspondent
physIQ, Inc
300 E. 5th Avenue, Suite 105
naperville,  IL  60563
Correspondent Contact george allen hides
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/30/2018
Decision Date 07/10/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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