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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 K012383
Device Name GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
Applicant
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Applicant Contact RENEE L FLUET
Correspondent
ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO,  CA  92121
Correspondent Contact RENEE L FLUET
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/27/2001
Decision Date 10/02/2001
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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