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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 K091308
Device Name ALARIS PC UNIT, MODELS 8000 AND 8015
Applicant
Cardinal Health 303,Inc.
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Applicant Contact Michelle J Badal
Correspondent
Cardinal Health 303,Inc.
10020 Pacific Mesa Blvd.
San Diego,  CA  92121
Correspondent Contact Michelle J Badal
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/04/2009
Decision Date 07/09/2009
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
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