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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 K926056
Device Name 9600 FLUOROSCOPIC IMAGING SYSTEM
Applicant
OEC-DIASONICS, INC.
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Applicant Contact THOMAS R MEYERS
Correspondent
OEC-DIASONICS, INC.
384 WRIGHT BROTHERS DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact THOMAS R MEYERS
Regulation Number892.1650
Classification Product Code
OXO  
Date Received12/01/1992
Decision Date 01/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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