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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 K211122
Device Name Novum IQ Large Volume Pump
Applicant
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield,  IL  60015
Applicant Contact Donna Haraden
Correspondent
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield,  IL  60015
Correspondent Contact Dhiraj Bizzul
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/15/2021
Decision Date 03/29/2024
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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