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 K131882
Device Name GEODESICEEG SYSTEM 400 SERIES (GES 400)
Applicant
ELECTRICAL GEODESICS, INC.
29611 SIMMONS ROAD
EUGENE,  OR  97405
Applicant Contact LINDA J BOVARD
Correspondent
ELECTRICAL GEODESICS, INC.
29611 SIMMONS ROAD
EUGENE,  OR  97405
Correspondent Contact LINDA J BOVARD
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
GWQ  
Date Received06/25/2013
Decision Date 02/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-