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, Transcutaneous, For Pain Relief
510(k) Number K112258
Device Name NEUROTECH PLUS
Applicant
Bio-Medical Research, Ltd.
Bmr House
Parkmore Business Park, W.
Galway,  IE EI
Applicant Contact ANNE-MARIE KEENAN
Correspondent
Bio-Medical Research, Ltd.
Bmr House
Parkmore Business Park, W.
Galway,  IE EI
Correspondent Contact ANNE-MARIE KEENAN
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   NYN  
Date Received08/05/2011
Decision Date 01/09/2012
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
-
-