Device Classification Name |
analyzer, gas, carbon-dioxide, partial pressure, blood-phase, indwelling
|
510(k) Number |
K901548 |
Device Name |
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS |
Applicant |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Applicant Contact |
ABATI, PHD |
Correspondent |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
ABATI, PHD |
Regulation Number | 868.1150
|
Classification Product Code |
|
Date Received | 04/03/1990 |
Decision Date | 01/14/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|