Device Classification Name |
monitor and/or control, level sensing, cardiopulmonary bypass
|
510(k) Number |
K900815 |
Device Name |
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL |
Applicant |
3M COMPANY |
6200 JACKSON RD. |
P.O. BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Applicant Contact |
JAMES BALUN |
Correspondent |
3M COMPANY |
6200 JACKSON RD. |
P.O. BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Correspondent Contact |
JAMES BALUN |
Regulation Number | 870.4340
|
Classification Product Code |
|
Date Received | 02/21/1990 |
Decision Date | 05/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|