FDA.reportPublic FDA data

510(k) K223446

Device
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Applicant
Signifier Medical Technologies, Ltd.
510(k) number
K223446
Product code
QNO
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-18
Date received
2022-11-15
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
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yasser Zayni
Address
5-17 Hammersmith Grove London GB W6 0LG W6 0LG

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QNO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240328eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)Signifier Medical Technologies, Ltd.2024-05-16
DEN200018eXciteOSA with remote and eXciteOSA without remoteSignifier Medical Technologies2021-02-05