De Novo DEN170056
- Device
- Parathyroid Detection (Model PTeye) System
- Contact
- al memmolo
- De Novo number
- DEN170056
- Product code
- QDF
- Regulation
- 878.4550
- Classification name
- parathyroid autofluorescence detection device
- Decision
- granted (DENG)
- Decision date
- 2018-11-02
- Date received
- 2017-09-25
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- QDF
- Device name
- Parathyroid Autofluorescence Detection Device
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4550
- Implant
- N
- Life sustain/support
- N