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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 K040985
Device Name PUMP CONNECTIVITY INTERFACE
Applicant
BAXTER HEALTHCARE CORP.
ONE BAXTER PKWY.
DEERFIELD,  IL  60015
Applicant Contact JENNIFER M PAINE
Correspondent
BAXTER HEALTHCARE CORP.
ONE BAXTER PKWY.
DEERFIELD,  IL  60015
Correspondent Contact JENNIFER M PAINE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/15/2004
Decision Date 11/30/2004
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
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