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 device, biofeedback
510(k) Number K122879
Device Name EEGER4 MODEL 4.3
Applicant
EEG SOFTWARE LLC
17625 MAYALL STREET
NORTHRIDGE,  CA  91325
Applicant Contact HOWARD LIGHTSTONE
Correspondent
EEG SOFTWARE LLC
17625 MAYALL STREET
NORTHRIDGE,  CA  91325
Correspondent Contact HOWARD LIGHTSTONE
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/19/2012
Decision Date 02/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-