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 Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K191322
Device Name E-EEGX, N-EEGX
Applicant
GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki,  FI FI-00510
Applicant Contact Joel Kent
Correspondent
GE Healthcare Finland Oy
Kuortaneenkatu 2
Helsinki,  FI FI-00510
Correspondent Contact Joel Kent
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWJ   MHX   MLD   OMC   ORT  
Date Received05/15/2019
Decision Date 01/22/2020
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
-
-