FDA 510(k), K113708, ORTHOSCAN MOBILE DI MINI C-ARM

FDA 510(k), K113708, ORTHOSCAN MOBILE DI MINI C-ARM

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510(K) Number: K113708
Device Name: ORTHOSCAN MOBILE DI MINI C-ARM
Manufacturer: CHRIS EAVES
Device Classification Name: Image-Intensified Fluoroscopic X-Ray System, Mobile
Regulation Number: OXO
Classification Product Code: 12/16/2011
Date Received: 01/05/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

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