Skip to contentDe Novo DEN200011
- Device
- Masimo SafetyNet
- Contact
- linus park
- De Novo number
- DEN200011
- Product code
- QVT
- Regulation
- 868.2250
- Classification name
- monitor for opioid induced impairment of oxygenation
- Decision
- granted (DENG)
- Decision date
- 2023-03-31
- Date received
- 2020-02-19
- Classification advisory
- Anesthesiology
- Review advisory
- Anesthesiology
- Type
- Direct
Current FDA Classification#
- Product code
- QVT
- Device name
- Monitor For Opioid Induced Impairment Of Oxygenation
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation
- 868.2250
- Implant
- N
- Life sustain/support
- N