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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number870.2700
Classification Product Code
DQA  
Date Received12/28/2010
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
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