Skip to contentDe Novo DEN220048
- Device
- Neoasis
- Contact
- george hutchinson
- De Novo number
- DEN220048
- Product code
- QWX
- Regulation
- 880.5405
- Classification name
- active noise attenuation system for infant incubators
- Decision
- granted (DENG)
- Decision date
- 2023-06-16
- Date received
- 2022-07-25
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- QWX
- Device name
- Active Noise Attenuation System For Infant Incubators
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.5405
- Implant
- N
- Life sustain/support
- N