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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K854863
Device Name FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact BRAIN STEMBAL
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact BRAIN STEMBAL
Regulation Number880.5725
Classification Product Code
LDR  
Date Received12/05/1985
Decision Date 02/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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