Device Classification Name |
oximeter
|
510(k) Number |
K884329 |
Device Name |
SAT-2 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 | 870.2700
|
Classification Product Code |
|
Date Received | 10/14/1988 |
Decision Date | 12/16/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|