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
|
|
Correspondent Contact |
MAREK PAWLOWSKI |
Regulation Number | 874.1820
|
Classification Product Code |
|
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
|
|
|