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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 K870242
Device Name INTERMATE(TM)
Applicant
Infusion Systems Corp.
5842 Research Dr.
Huntington Beach,  CA  92649
Applicant Contact DONALD B MILDER
Correspondent
Infusion Systems Corp.
5842 Research Dr.
Huntington Beach,  CA  92649
Correspondent Contact DONALD B MILDER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/21/1987
Decision Date 03/13/1987
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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