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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, water purification
510(k) Number K211035
Device Name U9000 Plus Ultrafilter
Applicant
Baxter Healthcare Corporation
25212 W. Illinois Route 120
Round Lake,  IL  60073
Applicant Contact Carina Pforr
Correspondent
Baxter Healthcare Corporation
25212 W. Illinois Route 120
Round Lake,  IL  60073
Correspondent Contact Carina Pforr
Regulation Number876.5665
Classification Product Code
FIP  
Date Received04/07/2021
Decision Date 10/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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