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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K192819
Device Name OEC Elite
Applicant
Ge Oec Medical Systems, Inc.
384 N Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact Kenny M Bello
Correspondent
Ge Oec Medical Systems, Inc.
384 N Wright Brothers Dr.
Salt Lake City,  UT  84116
Correspondent Contact Kenny M Bello
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   OWB  
Date Received10/01/2019
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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