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 K142064
Device Name GALILEO NT
Applicant
EB NEURO, S.P.A.
9001 WESLEYAN RD, STE 200
INDIANAPOLIS,  IN  46268
Applicant Contact ALLISON SCOTT, RAC
Correspondent
EB NEURO, S.P.A.
9001 WESLEYAN RD, STE 200
INDIANAPOLIS,  IN  46268
Correspondent Contact ALLISON SCOTT, RAC
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GWE   GWF   GWJ   GWQ   IKN  
JXE   OLV  
Date Received07/30/2014
Decision Date 02/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-