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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 K853393
Device Name INSULIN PUMP INSUMAT 229
Applicant
Medix Medical Electronics (U.S.A.), Inc.
C/O Weinberg-Doron & Company
750 Third Ave.
New York,  NY  10017
Applicant Contact & CO.
Correspondent
Medix Medical Electronics (U.S.A.), Inc.
C/O Weinberg-Doron & Company
750 Third Ave.
New York,  NY  10017
Correspondent Contact & CO.
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/12/1985
Decision Date 11/18/1985
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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