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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 K230041
Device Name Spectrum IQ Infusion System with Dose IQ Safety Software
Applicant
Baxter Healthcare Corporation
25212 W. Illinois Route 120
Round Lake,  IL  60073
Applicant Contact Meaghan Bonn
Correspondent
Baxter Healthcare Corporation
25212 W. Illinois Route 120
Round Lake,  IL  60073
Correspondent Contact Meaghan Bonn
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
PHC  
Date Received01/06/2023
Decision Date 03/31/2023
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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