Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K920915 |
Device Name |
CAPNOMED 100 STAND-ALONE ETCO2 MODULE |
Applicant |
MENNEN MEDICAL, INC. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Applicant Contact |
RONALD A BRANDT |
Correspondent |
MENNEN MEDICAL, INC. |
10123 MAIN ST. |
CLARENCE,
NY
14031
|
|
Correspondent Contact |
RONALD A BRANDT |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 02/27/1992 |
Decision Date | 03/23/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|