De Novo DEN170021
- Device
- SEM Scanner (Model 200)
- Contact
- ya-chen tonar
- De Novo number
- DEN170021
- Product code
- QEF
- Regulation
- 876.2100
- Classification name
- pressure ulcer management tool
- Decision
- granted (DENG)
- Decision date
- 2018-12-20
- Date received
- 2017-04-03
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QEF
- Device name
- Pressure Ulcer Management Tool
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation
- 876.2100
- Implant
- N
- Life sustain/support
- N