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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
Recalls CDRH Recalls
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