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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 K894487
Device Name IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
Applicant
Y
P.O. Box 85335
San Diego,  CA  92138
Applicant Contact G CHRISTIAN
Correspondent
Y
P.O. Box 85335
San Diego,  CA  92138
Correspondent Contact G CHRISTIAN
Regulation Number880.5725
Classification Product Code
LDR  
Date Received07/18/1989
Decision Date 09/27/1989
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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