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 Stimulator, Electrical, Evoked Response
510(k) Number K071969
Device Name SEN-4100 ELECTRIC STIMULATOR
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH,  CA  92610 -1601
Applicant Contact JACK COGGAN
Correspondent
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH,  CA  92610 -1601
Correspondent Contact JACK COGGAN
Regulation Number882.1870
Classification Product Code
GWF  
Date Received07/17/2007
Decision Date 10/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-