Device Dossier
Solar GI System - Gastrointestinal motility analysis system
Device Dossier for Solar GI System - Gastrointestinal motility analysis system (Gastrointestinal motility analysis system, Class IIa, sponsor Laborie…
- GMDN category: Gastrointestinal motility analysis system
Intended purpose
Intended to record, store, view, and analyze pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, Sphincter of oddi, small bowel, colon, and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area. Intended for use in male and female children and adults.