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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 K924879
Device Name EP 3000
Applicant
Oec-Diasonics, Inc.
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact JEFFDREY W WAGNER
Correspondent
Oec-Diasonics, Inc.
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Correspondent Contact JEFFDREY W WAGNER
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/28/1992
Decision Date 01/04/1993
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
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