NEURO CHECK DEVICE WITH IO-FLEX WIRE


Device Classification Name

stimulator, nerve

510(k) Number K110696
Device Name NEURO CHECK DEVICE WITH IO-FLEX WIRE
Applicant
BAXANO, INC.
655 river oaks pkwy
san jose, 
CA 
95134

Applicant Contact edward sinclair
Correspondent
BAXANO, INC.
655 river oaks pkwy
san jose, 
CA 
95134

Correspodent Contact edward sinclair
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 03/14/2011
Decision Date 07/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No