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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K252736
Device Name Hemotag Analysis Software (HAS)
Applicant
Aventusoft, LLC
3651 Fau Blvd.
Suite 300
Boca Raton,  FL  33431
Applicant Contact Gary Becker
Correspondent
Aventusoft, LLC
3651 Fau Blvd.
Suite 300
Boca Raton,  FL  33431
Correspondent Contact Gary Becker
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Codes
DPS   DQC   MWI  
Date Received08/28/2025
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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