Device Classification Name |
Analyzer, Gas, Oxygen, Gaseous-Phase
|
510(k) Number |
K123195 |
Device Name |
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES |
Applicant |
GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 |
HELSINKI,
FI
FIN-00510
|
|
Applicant Contact |
RAUNO RUOHO |
Correspondent |
GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 |
HELSINKI,
FI
FIN-00510
|
|
Correspondent Contact |
RAUNO RUOHO |
Regulation Number | 868.1720
|
Classification Product Code |
|
Date Received | 10/11/2012 |
Decision Date | 02/28/2013 |
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
|
|
|