Device Classification Name |
analyzer, gas, oxygen, partial pressure, blood-phase, indwelling
|
510(k) Number |
K843912 |
Device Name |
INTRAVASCULAR BLOOD GAS SYSTEM |
Applicant |
CARDIOVASCULAR DEVICES, INC. |
2801 BARRANCA |
IRVINE,
CA
92714
|
|
Applicant Contact |
JOHN L GEHRICH |
Correspondent |
CARDIOVASCULAR DEVICES, INC. |
2801 BARRANCA |
IRVINE,
CA
92714
|
|
Correspondent Contact |
JOHN L GEHRICH |
Regulation Number | 868.1200
|
Classification Product Code |
|
Date Received | 10/03/1984 |
Decision Date | 01/10/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|