Device Classification Name |
oximeter
|
510(k) Number |
K913790 |
Device Name |
SENSORMEDICS OXYSHUTTLE II(TM) |
Applicant |
SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Applicant Contact |
DAVID M TRUEBLOOD |
Correspondent |
SENSORMEDICS CORP. |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887 -4645
|
|
Correspondent Contact |
DAVID M TRUEBLOOD |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/23/1991 |
Decision Date | 02/26/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|