Device Classification Name |
Oximeter
|
510(k) Number |
K870163 |
Device Name |
BIOCHEM MICROSPAN 1040 OXIMETER |
Applicant |
BIOCHEM INTERNATIONAL, INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53186
|
|
Applicant Contact |
KEITH R HARPER |
Correspondent |
BIOCHEM INTERNATIONAL, INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53186
|
|
Correspondent Contact |
KEITH R HARPER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 01/14/1987 |
Decision Date | 03/03/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|