Device Classification Name |
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
|
510(k) Number |
K896311 |
Device Name |
OPTEX BLOOD GAS MONITORING SYSTEM |
Applicant |
OPTEX BIOMEDICAL |
2202 TIMBERLOCH PLACE, |
SUITE 135 |
THE WOODLANDS,
TX
77380
|
|
Applicant Contact |
JEFF KASOFF |
Correspondent |
OPTEX BIOMEDICAL |
2202 TIMBERLOCH PLACE, |
SUITE 135 |
THE WOODLANDS,
TX
77380
|
|
Correspondent Contact |
JEFF KASOFF |
Regulation Number | 868.1200
|
Classification Product Code |
|
Date Received | 11/01/1989 |
Decision Date | 01/03/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|