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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K914446
Device Name UROVIEW 2000, MODIFICATION
Applicant
Oec-Diasonics, Inc.
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact JOHN W TOLHURST
Correspondent
Oec-Diasonics, Inc.
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Correspondent Contact JOHN W TOLHURST
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/04/1991
Decision Date 01/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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