• 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 full-montage standard electroencephalograph
510(k) Number K791150
Device Name ELECTROENCEPHALOGRAPHS MODELS 7209,7213
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH,  CA  92610 -1601
Correspondent
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH,  CA  92610 -1601
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received06/15/1979
Decision Date 09/12/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-