Device Classification Name |
Oximeter
|
510(k) Number |
K862617 |
Device Name |
SENSORMEDICS OXYSHUTTLE(TM) |
Applicant |
SENSORMEDICS CORP. |
1630 S. STATE COLLEGE BLVD. |
ANAHEIM,
CA
92806
|
|
Applicant Contact |
MERTON A ROBINSON |
Correspondent |
SENSORMEDICS CORP. |
1630 S. STATE COLLEGE BLVD. |
ANAHEIM,
CA
92806
|
|
Correspondent Contact |
MERTON A ROBINSON |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 07/09/1986 |
Decision Date | 09/26/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|