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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 K172550
Device Name OEC Elite
Applicant
GE OEC Medical Systems, Inc.
384 Wright Brothers Drive
salt lake city,  UT  84116
Applicant Contact rachel schandel
Correspondent
GE OEC Medical Systems, Inc.
384 Wright Brothers Drive
salt lake city,  UT  84116
Correspondent Contact rachel schandel
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   OWB  
Date Received08/23/2017
Decision Date 11/16/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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