FDA 510(k), K140149, EPX-4440HD DIGITAL VIDEO PROCESSOR
FDA 510(k), K140149, EPX-4440HD DIGITAL VIDEO PROCESSOR
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510(K) Number: K140149
Device Name: EPX-4440HD DIGITAL VIDEO PROCESSOR
Manufacturer: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Device Classification Name: endoscope, accessories, image post-processing for color enhancement
Regulation Number: 876.1500
Classification Product Code: PEA
Date Received: 01/22/2014
Decision Date: 08/22/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EPX-4440HD DIGITAL VIDEO PROCESSOR
Manufacturer: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Device Classification Name: endoscope, accessories, image post-processing for color enhancement
Regulation Number: 876.1500
Classification Product Code: PEA
Date Received: 01/22/2014
Decision Date: 08/22/2014
Regulation Medical Specialty: Gastroenterology/Urology