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 Reduced- Montage Standard Electroencephalograph
510(k) Number K251550
Device Name NX01 (NX01)
Applicant
Naox Technologies Sas
62 Rue Mazarine
Paris,  FR 75006
Applicant Contact John Pappan
Correspondent
Naox Technologies Sas
62 Rue Mazarine
Paris,  FR 75006
Correspondent Contact John Pappan
Regulation Number882.1400
Classification Product Code
OMC  
Date Received05/21/2025
Decision Date 11/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-