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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 K051641
Device Name ALARIS SYSTEM PC UNIT, MODEL 8001
Applicant
Cardinal Health, Alaris Products
10221 Wateridge Circle
San Diego,  CA  92121 -2772
Applicant Contact STACY L LEWIS
Correspondent
Cardinal Health, Alaris Products
10221 Wateridge Circle
San Diego,  CA  92121 -2772
Correspondent Contact STACY L LEWIS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/20/2005
Decision Date 10/20/2005
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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