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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Cystometric, Non-Electric And Accessories
510(k) Number K872022
Device Name UROVIEW
Applicant
Oec-Diasonics, Inc.
2341 S. 2300 W.
P.O. Box 25296
Salt Lake City,  UT  84119
Applicant Contact JOHN W TOLHURST
Correspondent
Oec-Diasonics, Inc.
2341 S. 2300 W.
P.O. Box 25296
Salt Lake City,  UT  84119
Correspondent Contact JOHN W TOLHURST
Regulation Number876.4890
Classification Product Code
KQS  
Date Received05/26/1987
Decision Date 07/16/1987
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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