Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K901861 |
Device Name |
BIOCHEM 9100 MULTIGAS MONITOR |
Applicant |
BIOCHEM INTERNATIONAL, INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53186
|
|
Applicant Contact |
DAVID A UHEN |
Correspondent |
BIOCHEM INTERNATIONAL, INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53186
|
|
Correspondent Contact |
DAVID A UHEN |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 04/25/1990 |
Decision Date | 07/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|