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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K925311
Device Name TRILOGY INFUSION PUMP
Applicant
Ivion Corp.
2400 Industrial Ln.,
Suite 2000
Broomfield,  CO  80020
Applicant Contact AUDIE MARGRAVE
Correspondent
Ivion Corp.
2400 Industrial Ln.,
Suite 2000
Broomfield,  CO  80020
Correspondent Contact AUDIE MARGRAVE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/21/1992
Decision Date 08/16/1993
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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