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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System Accessories, Extracorporeal
510(k) Number K925581
Device Name BAXTER BIOSTAT 1000 UREA MONITOR
Applicant
Baxter Healthcare Corp
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact AMY STUEBER
Correspondent
Baxter Healthcare Corp
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact AMY STUEBER
Regulation Number876.5820
Classification Product Code
KXM  
Date Received11/05/1992
Decision Date 05/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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