Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K112840 |
Device Name |
CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR |
Applicant |
SEEBREATH AB |
MORKULLEVAGEN 31 |
BJARRED,
SE
23736
|
|
Applicant Contact |
ANETTE SJOGREN |
Correspondent |
SEEBREATH AB |
MORKULLEVAGEN 31 |
BJARRED,
SE
23736
|
|
Correspondent Contact |
ANETTE SJOGREN |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 09/29/2011 |
Decision Date | 07/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|