INVOTEC LARYNGEAL ELECTRODE


Device Classification Name

stimulator, nerve

510(k) Number K122040
Device Name INVOTEC LARYNGEAL ELECTRODE
Applicant
INVOTEC INTERNATIONAL, INC.
6833 phillips industrial blvd.
jacksonville, 
FL 
32256 -3029

Applicant Contact jeffrey l aull
Correspondent
INVOTEC INTERNATIONAL, INC.
6833 phillips industrial blvd.
jacksonville, 
FL 
32256 -3029

Correspodent Contact jeffrey l aull
Regulation Number 874.1820
Classification Product Code
ETN  
Date Received 07/12/2012
Decision Date 10/31/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No