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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 K083689
Device Name INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
Applicant
B.Braun Medical, Inc.
1601 Wallace Dr., Suite 150
Carrollton,  TX  75006
Applicant Contact LINDA MORGAN
Correspondent
B.Braun Medical, Inc.
1601 Wallace Dr., Suite 150
Carrollton,  TX  75006
Correspondent Contact LINDA MORGAN
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/12/2008
Decision Date 07/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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