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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 K072105
Device Name ALARIS SYSTEM WITH MMS, MODEL 8XXX
Applicant
Cardinal Health 303,Inc.
10221 Wateridge Cir.
San Diego,  CA  92121
Applicant Contact STACY L LEWIS
Correspondent
Cardinal Health 303,Inc.
10221 Wateridge Cir.
San Diego,  CA  92121
Correspondent Contact STACY L LEWIS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/31/2007
Decision Date 12/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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