510(k) DEN200018
DEN200018 is an FDA 510(k) premarket notification submitted by Signifier Medical Technologies for the device "eXciteOSA with remote and eXciteOSA without remote". The FDA issued a decision of De Novo Granted on February 5, 2021. The device falls under product code QNO (Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea), a Class II device regulated under 21 CFR 872.5575. Signifier Medical Technologies has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 5, 2021
- Date Received
- March 24, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
- Device Class
- Class II
- Regulation Number
- 872.5575
- Review Panel
- DE
- Submission Type
A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.