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 Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K230826
Device Name Modius Sleep
Applicant
Neurovalens Ltd.
8 Carmagrim Road
Portglenone,  GB BT44 8BP
Applicant Contact Jason McKeown
Correspondent
Neurovalens Ltd.
8 Carmagrim Road
Portglenone,  GB BT44 8BP
Correspondent Contact Jason McKeown
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received03/24/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04595968
Reviewed by Third Party No
Combination Product No
-
-