NEUROTECH PLUS


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, west
galway, 

IE

ei

Applicant Contact anne-marie keenan
Correspondent
BIO-MEDICAL RESEARCH, LTD.
bmr house
parkmore business park, west
galway, 

IE

ei

Correspodent Contact anne-marie keenan
Regulation Number 882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   NYN  
Date Received 08/05/2011
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