Device Classification Name |
Conserver, Oxygen
|
510(k) Number |
K962944 |
Device Name |
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) |
Applicant |
TRANSTRACHEAL SYSTEMS |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Applicant Contact |
LEWIS W WARD |
Correspondent |
TRANSTRACHEAL SYSTEMS |
4655 KIRKWOOD COURT |
BOULDER,
CO
80301
|
|
Correspondent Contact |
LEWIS W WARD |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/26/1996 |
Decision Date | 10/23/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|