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 Full-Montage Standard Electroencephalograph
510(k) Number K171781
Device Name eVox System
Applicant
Evoke Neuroscience, Inc.
200 Valencia Dr.
Suite 109
Jacksonville,  NC  28546
Applicant Contact David Hagedorn
Correspondent
Evoke Neuroscience
200 Valencia Dr.
Suite 109
Jacksonville,  NC  28546
Correspondent Contact Marinela Gombosev
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GWJ  
Date Received06/15/2017
Decision Date 12/13/2017
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
-
-