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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
Applicant
GE OEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Applicant Contact TED PARROT
Correspondent
GE OEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Correspondent 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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