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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 Drive
salt lake city,  UT  84116
Applicant Contact kenny m bello
Correspondent
GE OEC Medical Systems, Inc.
384 N Wright Brothers Drive
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
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