Device Classification Name |
detector, bubble, cardiopulmonary bypass
|
510(k) Number |
K940651 |
Device Name |
SARNS ULTRASONIC AIR SENSOR |
Applicant |
3M HEALTH CARE, SARNS |
6200 JACKSON RD. |
PO BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Applicant Contact |
TIMOTHY J KRIEWALL, PH.D. |
Correspondent |
3M HEALTH CARE, SARNS |
6200 JACKSON RD. |
PO BOX 1247 |
ANN ARBOR,
MI
48106
|
|
Correspondent Contact |
TIMOTHY J KRIEWALL, PH.D. |
Regulation Number | 870.4205
|
Classification Product Code |
|
Date Received | 02/15/1994 |
Decision Date | 05/24/1994 |
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
|
|
|