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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
510(k) Number K250680
Device Name Bayesian Health Sepsis Flagging Device
Applicant
Bayesian Health, Inc.
2 River Ter.
New York,  NY  10282
Applicant Contact Rachael Weir
Correspondent
Bayesian Health, Inc.
2 River Ter.
New York,  NY  10282
Correspondent Contact Thomas Ford
Classification Product Code
SAK  
Date Received03/06/2025
Decision Date 04/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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