Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
510(k) Number |
K963177 |
Device Name |
TED 191 |
Applicant |
TELEDYNE BROWN ENGINEERING |
601 13TH STREET, N.W. |
SUITE 500 NORTH |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
TERRY G MAHN |
Correspondent |
TELEDYNE BROWN ENGINEERING |
601 13TH STREET, N.W. |
SUITE 500 NORTH |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
TERRY G MAHN |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 08/14/1996 |
Decision Date | 11/13/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|