7f078799-3912-42d1-b42d-931a30bc38b9UpdatePublished52019-11-082017-04-05In Commercial Distribution04961333230495PrimaryGS134961333230496PackageGS10496133323049525In Commercial DistributionBAGN/A7183-4500083211284PENTAX OF AMERICA, INC.1Tongue Arrays
falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK95479800035053Manometric gastrointestinal motility analysis systemAn assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.falseActiveKLAMonitor, Esophageal Motility, And Tubefalsefalse