Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
|
510(k) Number |
K870911 |
Device Name |
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY |
Applicant |
AMERICAN BENTLEY |
P.O. BOX 19522 |
IRVINE,
CA
92713
|
|
Applicant Contact |
DONALD A RAIBLE |
Correspondent |
AMERICAN BENTLEY |
P.O. BOX 19522 |
IRVINE,
CA
92713
|
|
Correspondent Contact |
DONALD A RAIBLE |
Regulation Number | 868.1150
|
Classification Product Code |
|
Date Received | 03/06/1987 |
Decision Date | 05/29/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|