Product code QIS
- Device name
- Esophageal, Mucosal, Electrical Characterization
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1450
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
- Source
- FDA openFDA device classification dataset