Device Classification Name |
Stimulator, Nerve
|
510(k) Number |
K925640 |
Device Name |
XOMED-TREACE EMG ENDOTRACHEAL TUBEEN |
Applicant |
XOMED-TREACE, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Applicant Contact |
TERRY C MCMAHON |
Correspondent |
XOMED-TREACE, INC. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent Contact |
TERRY C MCMAHON |
Regulation Number | 874.1820
|
Classification Product Code |
|
Date Received | 11/09/1992 |
Decision Date | 08/17/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|