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
|
|
Correspondent Contact |
JEFFREY L AULL |
Regulation Number | 874.1820
|
Classification Product Code |
|
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
|
|
|