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 K951641
Device Name NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
Applicant
THE MAGSTIM COMPANY LTD.
SPRING GARDENS, WHITLAND
DYFED, WALES,  GB SA34 OHR
Applicant Contact CHRIS HOVEY
Correspondent
THE MAGSTIM COMPANY LTD.
SPRING GARDENS, WHITLAND
DYFED, WALES,  GB SA34 OHR
Correspondent Contact CHRIS HOVEY
Regulation Number874.1820
Classification Product Code
ETN  
Date Received03/21/1995
Decision Date 05/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-