510(k) DEN200018
- Device
- eXciteOSA with remote and eXciteOSA without remote
- Applicant
- Signifier Medical Technologies
- 510(k) number
- DEN200018
- Product code
- QNO
- Decision
- Unknown (DENG)
- Decision date
- 2021-02-05
- Date received
- 2020-03-24
- Regulation
- 872.5575
- Classification name
- Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Yasser Zayni
- Address
- The Triangle, 6th Floor, Hammersmith Grove, Hammersmith London GB W6 0LG W6 0LG
FDA Registration Numbers#
- 3033509895
- 3013445086
- 3018192374
- 3017737771
- 3017430550
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QNO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | 2024-05-16 |
| K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | 2023-01-18 |