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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
510(k) Number K850169
Device Name ERIS URO-DIAGNOSTIC SYSTEM
Applicant
Eris Medical Technology
1308 Springfield Ave.
New Providence,  NJ  07974
Applicant Contact DAVID SUGGS
Correspondent
Eris Medical Technology
1308 Springfield Ave.
New Providence,  NJ  07974
Correspondent Contact DAVID SUGGS
Regulation Number876.1800
Classification Product Code
FFG  
Date Received01/16/1985
Decision Date 04/22/1985
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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