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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
Recalls CDRH Recalls
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