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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K170752
Device Name OEC Elite
Applicant
OEC Medical Systems, Inc.
384 Wright Brothers Drive
Salt Lake City,  UT  84116
Applicant Contact Helen Peng
Correspondent
OEC Medical Systems, Inc.
384 Wright Brothers Drive
Salt Lake City,  UT  84116
Correspondent Contact Helen Peng
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received03/13/2017
Decision Date 05/19/2017
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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