Device Classification Name |
Computer, Diagnostic, Pre-Programmed, Single-Function
|
510(k) Number |
K893392 |
Device Name |
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER |
Applicant |
BAXTER HEALTHCARE CORP. |
P.O. BOX 11150 |
SANTA ANA,
CA
92711
|
|
Applicant Contact |
EDWARD GUILMETTE |
Correspondent |
BAXTER HEALTHCARE CORP. |
P.O. BOX 11150 |
SANTA ANA,
CA
92711
|
|
Correspondent Contact |
EDWARD GUILMETTE |
Regulation Number | 870.1435
|
Classification Product Code |
|
Date Received | 05/01/1989 |
Decision Date | 06/20/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|