PAIRED HYDROGEL ELECTRODE


Device Classification Name

stimulator, nerve

510(k) Number K110138
Device Name PAIRED HYDROGEL ELECTRODE
Applicant
NEUROVISION MEDICAL PRODUCTS, INC.
2225 sperry ave, suite 1000
ventura, 
CA 
93003

Applicant Contact christine vergely
Correspondent
NEUROVISION MEDICAL PRODUCTS, INC.
2225 sperry ave, suite 1000
ventura, 
CA 
93003

Correspodent Contact christine vergely
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 01/18/2011
Decision Date 04/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No