Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
|
510(k) Number |
K891013 |
Device Name |
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
DAVID H MUELLER |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
DAVID H MUELLER |
Regulation Number | 868.1150
|
Classification Product Code |
|
Date Received | 02/28/1989 |
Decision Date | 08/02/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|