NEXT GEN EMG ENDOTRACHEAL TUBE


Device Classification Name

stimulator, nerve

510(k) Number K112686
Device Name NEXT GEN EMG ENDOTRACHEAL TUBE
Applicant
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Applicant Contact marek pawlowski
Correspondent
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Correspodent Contact marek pawlowski
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 09/15/2011
Decision Date 06/27/2012
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

Recalls CDRH Recalls