De Novo DEN220091
- Device
- Dream Sock
- Contact
- jim fidacaro
- De Novo number
- DEN220091
- Product code
- QYU
- Regulation
- 870.2705
- Classification name
- infant pulse rate and oxygen saturation monitor for over-the-counter use
- Decision
- granted (DENG)
- Decision date
- 2023-11-08
- Date received
- 2022-12-14
- Classification advisory
- Cardiovascular
- Review advisory
- Cardiovascular
- Type
- Direct
Current FDA Classification
- Product code
- QYU
- Device name
- Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 870.2705
- Implant
- N
- Life sustain/support
- N
Related GUDID Devices
| Primary DI | Device | Company | Published |
|---|
| 00810099090819 | Dream Sock App | Owlet Baby Care Inc. | 2024-02-12 |