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 K130403
Device Name MAGSTIM DOUBLE 70-2 COIL
Applicant
The Magstim Company , Ltd.
101 Milk St.
Methuen,  MA  01844
Applicant Contact J. P OUELLETTE
Correspondent
The Magstim Company , Ltd.
101 Milk St.
Methuen,  MA  01844
Correspondent Contact J. P OUELLETTE
Regulation Number882.1870
Classification Product Code
GWF  
Date Received02/19/2013
Decision Date 08/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-