Device Classification Name |
Oximeter
|
510(k) Number |
K093881 |
Device Name |
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR |
Applicant |
GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 |
HELSINKI,
FI
FIN-00510
|
|
Applicant Contact |
TOMMI JOKINIEMI |
Correspondent |
GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 |
HELSINKI,
FI
FIN-00510
|
|
Correspondent Contact |
TOMMI JOKINIEMI |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/18/2009 |
Decision Date | 03/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Clinical Trials |
NCT00881829
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|