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, nerve
510(k) Number K083242
Device Name NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
Applicant
THE MAGSTIM COMPANY LTD.
SPRING GARDENS
WHITLAND
CARMARTHENSHIRE, WALES,  GB SA34 OHR
Applicant Contact ANWEN EVANS
Correspondent
THE MAGSTIM COMPANY LTD.
SPRING GARDENS
WHITLAND
CARMARTHENSHIRE, WALES,  GB SA34 OHR
Correspondent Contact ANWEN EVANS
Regulation Number874.1820
Classification Product Code
ETN  
Date Received11/03/2008
Decision Date 07/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-