FDA 510(k), K161355, invendoscopy E200 System

510(K) Number: K161355
Device Name: invendoscopy E200 System
Manufacturer: Invendo Medical GmbH
Device Classification Name: colonoscope and accessories, flexible/rigid
Regulation Number: 876.1500
Classification Product Code: FDF
Date Received: 05/16/2016
Decision Date: 08/25/2016
Regulation Medical Specialty: Gastroenterology/Urology

Total pages: 1003
Fully redacted pages: 896
Content pages: 107