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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K843531
Device Name ASN MONITOR SINGLE NEEDLE MONITOR
Applicant
Organon Teknika Corp.
5300 S. Portland Ave.
Oklahoma City,  OK  73119
Applicant Contact VAN ANTWERPEN
Correspondent
Organon Teknika Corp.
5300 S. Portland Ave.
Oklahoma City,  OK  73119
Correspondent Contact VAN ANTWERPEN
Regulation Number876.5820
Classification Product Code
KOC  
Date Received09/07/1984
Decision Date 11/16/1984
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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