FDA 510(k), K091070, MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM

510(K) Number: K091070
Device Name: MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
Manufacturer: SIERRA SCIENTIFIC INSTRUMENTS, INC.
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: 876.1725
Classification Product Code: FFX
Date Received: 04/14/2009
Decision Date: 05/19/2009
Regulation Medical Specialty: Gastroenterology/Urology

595 pages (1,419 of 2014 original pages are fully redacted)