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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 K873985
Device Name FLUORO COVER
Applicant
Condor Medical
101 N.700 W.
No Salt Lake City,  UT  84054
Applicant Contact JAMES E WILLIAMS
Correspondent
Condor Medical
101 N.700 W.
No Salt Lake City,  UT  84054
Correspondent Contact JAMES E WILLIAMS
Regulation Number892.1650
Classification Product Code
JAA  
Date Received09/30/1987
Decision Date 01/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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