• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name full-montage standard electroencephalograph
510(k) Number K112817
Device Name MICROEEG SYSTEM
Original Applicant
BIO-SIGNAL GROUP CORPORATION
760 parkside ave
brooklyn,  NY  11226
Original Contact anderson micu
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received09/28/2011
Decision Date 06/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-