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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K243855
Device Name BD Alaris Infusion System with Guardrails Suite MX
Applicant
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Applicant Contact Darin Oppenheimer
Correspondent
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Correspondent Contact Darin Oppenheimer
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
CCK   MEA   PHC  
Date Received12/16/2024
Decision Date 04/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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