Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K882661 |
Device Name |
ACUMED 9000 ETCO(2) MONITOR |
Applicant |
ACUMED TECHNOLOGIES, INC. |
P.O. BOX 0925 |
WAUKESHA,
WI
53187
|
|
Applicant Contact |
DANIEL F CARSTEN |
Correspondent |
ACUMED TECHNOLOGIES, INC. |
P.O. BOX 0925 |
WAUKESHA,
WI
53187
|
|
Correspondent Contact |
DANIEL F CARSTEN |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 06/28/1988 |
Decision Date | 08/24/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|