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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 K884307
Device Name IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262
Applicant
Y
P.O. Box 85335
San Diego,  CA  92138
Applicant Contact KIMBERLY M CARLSON
Correspondent
Y
P.O. Box 85335
San Diego,  CA  92138
Correspondent Contact KIMBERLY M CARLSON
Regulation Number880.5725
Classification Product Code
LDR  
Date Received10/13/1988
Decision Date 11/01/1988
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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