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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 K093881
Device Name TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
Original Applicant
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki,  FI fin-00510
Original Contact tommi jokiniemi
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received12/18/2009
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
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