Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K240328
Device Name eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Applicant
Signifier Medical Technologies, Ltd.
5-17 Hammersmith Grove
London,  GB W6 0LG
Applicant Contact Yasser Zayni
Correspondent
Regchoice, LLC
13014 N. Dale Mabry Hwy Suite 803
Suite 803
Tampa,  FL  33618
Correspondent Contact Darren Scheer
Regulation Number872.5575
Classification Product Code
QNO  
Date Received02/05/2024
Decision Date 05/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-