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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K024012
Device Name OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
Original Applicant
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city,  UT  84116
Original Contact jeff wagner
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Codes
OWB   OXO  
Date Received12/04/2002
Decision Date 03/20/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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