• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name amplifier, physiological signal
510(k) Number K121996
Device Name BE PLUS LTM AMPLIFIER GWI AMPLIFIER
Original Applicant
EB NEURO, S.P.A.
9001 wesleyan road
indianapolis,  IN  46268
Original Contact allison scott
Regulation Number882.1835
Classification Product Code
GWL  
Date Received07/09/2012
Decision Date 08/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-