FDA 510(k), K062222, UNITIP HIGH RESOLUTION CATHETER

510(K) Number: K062222
Device Name: UNITIP HIGH RESOLUTION CATHETER
Manufacturer: UNISENSOR AG
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 08/02/2006
Decision Date: 03/15/2007
Regulation Medical Specialty: Gastroenterology/Urology

144 pages (32 of 176 original pages are fully redacted)