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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Heart Failure Status Indicator
510(k) Number K251293
Device Name CardioVision
Applicant
Icardio.Ai
8601 Beverly Blvd.
Floor 2
West Hollywood,  CA  90048
Applicant Contact Roman Sandler
Correspondent
Icardio.Ai
8601 Beverly Blvd.
Floor 2
West Hollywood,  CA  90048
Correspondent Contact Joseph Sokol
Regulation Number870.2200
Classification Product Code
QUO  
Date Received04/25/2025
Decision Date 11/21/2025
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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