FDA 510(k), K151086, ManoScan System

510(K) Number: K151086
Device Name: ManoScan System
Manufacturer: GIVEN IMAGING LTD.
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 04/22/2015
Decision Date: 04/28/2016
Regulation Medical Specialty: Gastroenterology/Urology

814 pages (3,110 of 3,924 original pages are fully redacted)