TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR


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

Correspodent Contact tatja pasanen
Regulation Number 870.2700
Classification Product Code
DQA  
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