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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 K840823
Device Name TREONIC C30
Applicant
Vickers America Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Vickers America Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5725
Classification Product Code
LDR  
Date Received02/24/1984
Decision Date 03/23/1984
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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