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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 K003837
Device Name FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
Original Applicant
GE OEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city,  UT  84116
Original Contact ted parrot
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received12/12/2000
Decision Date 03/12/2001
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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