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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 K992506
Device Name MINI 6800 DIGITAL MOBILE C-ARM
Applicant
GE DEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Applicant Contact TED L PARROT
Correspondent
GE DEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact TED L PARROT
Regulation Number892.1650
Classification Product Code
OXO  
Date Received07/27/1999
Decision Date 08/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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