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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K852433
Device Name INFUSAFE 205 CATOLOG NO. 205.000
Applicant
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
C/O WEINBERG-DORON & COMPANY
750 THIRD AVENUE
NEW YORK,  NY  10017
Applicant Contact CO.
Correspondent
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
C/O WEINBERG-DORON & COMPANY
750 THIRD AVENUE
NEW YORK,  NY  10017
Correspondent Contact CO.
Regulation Number880.2420
Classification Product Code
FLN  
Date Received06/10/1985
Decision Date 06/27/1985
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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