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 Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K092844
Device Name GEOSOURCE
Applicant
ELECTRICAL GEODESICS, INC.
1600 MILLRACE DR.
SUITE 307
EUGENE,  OR  97403 -1995
Applicant Contact PAUL HOLMAN
Correspondent
ELECTRICAL GEODESICS, INC.
1600 MILLRACE DR.
SUITE 307
EUGENE,  OR  97403 -1995
Correspondent Contact PAUL HOLMAN
Regulation Number882.1400
Classification Product Code
OLX  
Date Received09/15/2009
Decision Date 12/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-