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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 K191877
Device Name FLUOROspeed
Shimadzu Corporation
1 Nishinokyo-Kuwabaracho Nakagyo-ku
kyoto,  JP 604-8511
Applicant Contact toshio kadowaki
Kamm & Associates
8870 Ravello Ct
naples,  FL  34114
Correspondent Contact daniel kamm
Regulation Number892.1650
Classification Product Code
Date Received07/15/2019
Decision Date 08/05/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No