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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph, ambulatory (without analysis)
510(k) Number K173156
Device Name Integrated CardioRespiratory System
Sensydia, Inc.
907 Westwood Boulevard, Suite 358
Los Angeles,  CA  90024
Applicant Contact Thomas Bruggere
Experien Group, LLC
224 Airport Parkway, Suite 250
San Jose,  CA  95110
Correspondent Contact Anna Libman
Regulation Number870.2800
Classification Product Code
Subsequent Product Code
Date Received09/29/2017
Decision Date 06/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No