FDA device listing
eXciteOSA control unit only pack (warranty replacement) (17000),eXciteOSA mouthpiece replacement (16000),eXciteOSA…
FDA device listing 2017451702 · Signifier Medical Technologies Limited
Key facts
| Proprietary names | eXciteOSA control unit only pack (warranty replacement) (17000),eXciteOSA mouthpiece replacement (16000),eXciteOSA remote control only (14001),eXciteOSA remote control only (warranty replacement) (14000),eXciteOSA starter kit - without remote control (13010),eXciteOSA starter kit - with remote control (18010) |
|---|---|
| Owner/operator | Signifier Medical Technologies Limited |
| Owner/operator number | 10080665 |
| Premarket submissions | K240328 |
| Product codes | QNO |
| Device names | QNO - Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.5575 |
| Review panels | Dental |
| Registered establishments | SIGNIFIER MEDICAL TECHNOLOGIES LIMITED |
| Establishment registrations | 3018192374 |
| FEI numbers | 3018192374 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database