Device Dossier
Gastrointestinal motility analysis system
Device Dossier for Gastrointestinal motility analysis system (Gastrointestinal motility analysis system, Class IIa, sponsor Endotherapeutics). ARTG…
- GMDN category: Gastrointestinal motility analysis system
- Sponsor: Endotherapeutics
Intended purpose
The Zvu Esophageal High Resolution Impedance Manometry (HRiM) Probe is intended for use by gastroenterologists, surgeons, and medically trained personnel for gastrointestinal tract studies to obtain a high resolution mapping of peristaltic activity or pressure within the organs, and to allow storage of the corresponding data. The device is used in conjunction with a manometry system from Diversatek Healthcare. Studies performed with this system require skill interpretation by a physician to aid in making a diagnosis of esophageal motility disorders. This device is indicated for use on adult populations only.