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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 K870820
Device Name IVY COMMANDER (MODEL 500)
Applicant
Ivy Medical, Inc.
7411 Washington Ave. S.
Minneapolis,  MN  55435
Applicant Contact FRED R LEGRAND
Correspondent
Ivy Medical, Inc.
7411 Washington Ave. S.
Minneapolis,  MN  55435
Correspondent Contact FRED R LEGRAND
Regulation Number880.5725
Classification Product Code
LDR  
Date Received03/03/1987
Decision Date 01/20/1988
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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