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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name detector and alarm, arrhythmia
510(k) Number K231276
Device Name SmartCardia 7L Platform
Applicant
SmartCardia SA
EPFL Innovation Park Building C
Lausanne,  CH 1015
Applicant Contact Srinivasan Murali
Correspondent
Steurer Consulting Group LLC
800 Blue Quail Rd
Keller,  TX  76248
Correspondent Contact Robert Steurer
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
DRG  
Date Received05/02/2023
Decision Date 08/30/2023
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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