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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 K173084
Device Name Spectrum IQ Infusion System, Dose IQ Safety Software
Applicant
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake,  IL  60073
Applicant Contact Dhiraj Bizzul
Correspondent
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake,  IL  60073
Correspondent Contact Dhiraj Bizzul
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
PHC  
Date Received09/29/2017
Decision Date 05/11/2018
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
Recalls CDRH Recalls
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