Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
|
510(k) Number |
K953893 |
Device Name |
PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM |
Applicant |
BIOMEDICAL SENSORS, INC. |
SHORT ST. |
HIGH WYCOMBE, BUCKS,
GB
HP11 2QH
|
|
Applicant Contact |
KARIMA HEBRI |
Correspondent |
BIOMEDICAL SENSORS, INC. |
SHORT ST. |
HIGH WYCOMBE, BUCKS,
GB
HP11 2QH
|
|
Correspondent Contact |
KARIMA HEBRI |
Regulation Number | 868.1150
|
Classification Product Code |
|
Date Received | 08/17/1995 |
Decision Date | 11/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|