De Novo DEN180067
- Device
- Mucosal Integrity Conductivity (MI) Test System
- Contact
- laura l boll
- De Novo number
- DEN180067
- Product code
- QIS
- Regulation
- 876.1450
- Classification name
- esophageal, mucosal, electrical characterization
- Decision
- granted (DENG)
- Decision date
- 2019-12-23
- Date received
- 2018-12-17
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QIS
- Device name
- Esophageal, Mucosal, Electrical Characterization
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.1450
- Implant
- N
- Life sustain/support
- N