Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K970209 |
Device Name |
CAPNOCHECK PLUS |
Applicant |
BCI INTL., INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
DONALD J ALEXANDER |
Correspondent |
BCI INTL., INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
DONALD J ALEXANDER |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 01/21/1997 |
Decision Date | 04/18/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|