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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 K133532
Device Name ALARIS SYSTEM WITH GUARDRAILS SUITE MX
Applicant
CAREFUSION 303, INC.
10020 PACIFIC MESA BLVD.
SAN DIEGO,  CA  92121
Applicant Contact CHRISTINE CATON
Correspondent
CAREFUSION 303, INC.
10020 PACIFIC MESA BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact CHRISTINE CATON
Regulation Number880.5725
Classification Product Code
FRN  
Date Received11/18/2013
Decision Date 08/21/2014
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
Recalls CDRH Recalls
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