Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K873856 |
Device Name |
BIOCHEM 9090 CAPNOGRAPH/SAO2 |
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 | 868.1400
|
Classification Product Code |
|
Date Received | 09/22/1987 |
Decision Date | 12/17/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|