De Novo DEN200018
- Device
- eXciteOSA with remote and eXciteOSA without remote
- Contact
- yasser zayni
- De Novo number
- DEN200018
- Product code
- QNO
- Regulation
- 872.5575
- Classification name
- neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea
- Decision
- granted (DENG)
- Decision date
- 2021-02-05
- Date received
- 2020-03-24
- Classification advisory
- Dental
- Review advisory
- Dental
- Type
- Direct
Current FDA Classification#
- Product code
- QNO
- Device name
- Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
- Medical specialty
- Dental
- Device class
- 2
- Regulation
- 872.5575
- Implant
- N
- Life sustain/support
- N