De Novo DEN230050
- Device
- Body Temperature Software (BTS)
- Contact
- nathan austin
- De Novo number
- DEN230050
- Product code
- QZA
- Regulation
- 880.2915
- Classification name
- body temperature sensing software
- Decision
- granted (DENG)
- Decision date
- 2023-12-15
- Date received
- 2023-07-17
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- QZA
- Device name
- Body Temperature Sensing Software
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.2915
- Implant
- N
- Life sustain/support
- N