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 Electrode, Cortical
510(k) Number K180761
Device Name SD LTM STIM Cortical Stimulator
Applicant
Micromed S.P.A.
Via Giotto 2
Mogliano Veneto,  IT 31021
Applicant Contact Monica Camillo
Correspondent
Spectramedex, LLC
3215 Golf Rd. #149
Delafield,  WI  53018
Correspondent Contact John Ziobro
Regulation Number882.1310
Classification Product Code
GYC  
Date Received03/23/2018
Decision Date 06/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-