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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 K123603
Device Name OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
Applicant
Ge Healthcare Surgery GE Oec Medical Systems, Inc.
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact GERALD BUSS
Correspondent
Ge Healthcare Surgery GE Oec Medical Systems, Inc.
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Correspondent Contact GERALD BUSS
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received11/21/2012
Decision Date 05/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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