De Novo DEN230041
- Device
- Sleep Apnea Feature
- Contact
- hon pak
- De Novo number
- DEN230041
- Product code
- QZW
- Regulation
- 868.2378
- Classification name
- over-the-counter device to assess risk of sleep apnea
- Decision
- granted (DENG)
- Decision date
- 2024-02-06
- Date received
- 2023-05-31
- Classification advisory
- Anesthesiology
- Review advisory
- Anesthesiology
- Type
- Direct
Current FDA Classification#
- Product code
- QZW
- Device name
- Over-The-Counter Device To Assess Risk Of Sleep Apnea
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation
- 868.2378
- Implant
- N
- Life sustain/support
- N