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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 K251640
Device Name SIGMA Spectrum Infusion Pump with Master Drug Library
Applicant
Baxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Applicant Contact Jessica Andreshak
Correspondent
Baxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake,  IL  60015
Correspondent Contact Jessica Andreshak
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
PHC  
Date Received05/29/2025
Decision Date 07/28/2025
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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