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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 K051490
Device Name GE OEC EVERVIEW 7500
Applicant
GE OEC MEDICAL SYSTEMS, INC.
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Applicant Contact SUSAN SCHMIDT
Correspondent
GE OEC MEDICAL SYSTEMS, INC.
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact SUSAN SCHMIDT
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received06/06/2005
Decision Date 07/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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