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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulmonary Hypertension Machine Learning-Based Notification Software
510(k) Number K233666
Device Name CorVista System with PH Add-On
Applicant
Analytics for Life, Inc.
160 Bloor Street East
Suite 910
Toronto,  CA M4W 1B9
Applicant Contact Gabrielle Zaeska
Correspondent
Analytics for Life, Inc.
First Canadian Place
100 King Street West, Suite 5600
Toronto,  CA M5X 1C9
Correspondent Contact Gabrielle Zaeska
Classification Product Code
SAT  
Date Received11/15/2023
Decision Date 04/05/2024
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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