Device Classification Name |
Oximeter
|
510(k) Number |
K103802 |
Device Name |
TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR |
Applicant |
GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 |
HELSINKI,
FI
FIN-00510
|
|
Applicant Contact |
TATJA PASANEN |
Correspondent |
GE HEALTHCARE FINLAND OY |
KUORTANEENKATU 2 |
HELSINKI,
FI
FIN-00510
|
|
Correspondent Contact |
TATJA PASANEN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/28/2010 |
Decision Date | 08/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00881829
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|