K240328

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

510(k) number
K240328
Device name
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Applicant
Signifier Medical Technologies, Ltd. GB
Product code
QNO — Neuromuscular Tongue Muscle Stimulator For The Reduc
Decision date
2024-05-16
Date received
2024-02-05
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K240328.pdf

Official FDA record: K240328
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.