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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 K041738
Device Name BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)
Applicant
Baxter Healthcare Corporation
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact KAREN SPRANGER
Correspondent
Baxter Healthcare Corporation
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact KAREN SPRANGER
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
MEB  
Date Received06/28/2004
Decision Date 07/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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