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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 K211218
Device Name BD Alaris System with Guardrails Suite MX v12.1.2
Applicant
CareFusion 303 Inc.
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Applicant Contact Laurie Cartwright
Correspondent
CareFusion 303 Inc.
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Correspondent Contact Laurie Cartwright
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Codes
CCK   MEA   PHC  
Date Received04/23/2021
Decision Date 07/21/2023
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
Recalls CDRH Recalls
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