• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea
510(k) Number K223446
Device Name eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Signifier Medical Technologies Ltd
5-17 Hammersmith Grove
London,  GB W6 0LG
Applicant Contact Yasser Zayni
RegChoice LLC
13014 N. Dale Mabry Hwy STE 803
Tampa,  FL  33618
Correspondent Contact Darren Scheer
Regulation Number872.5575
Classification Product Code
Date Received11/15/2022
Decision Date 01/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No