Device Classification Name |
Device, Fixation, Tracheal Tube
|
510(k) Number |
K941384 |
Device Name |
TRAKEEZ |
Applicant |
ERGOMED, INC. |
5426 BILLINGTON DR. |
SAN ANTONIO,
TX
78230
|
|
Applicant Contact |
J.T. BOWLIN |
Correspondent |
ERGOMED, INC. |
5426 BILLINGTON DR. |
SAN ANTONIO,
TX
78230
|
|
Correspondent Contact |
J.T. BOWLIN |
Regulation Number | 868.5770
|
Classification Product Code |
|
Date Received | 03/22/1994 |
Decision Date | 04/19/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|