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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 K101871
Device Name TRUSIGNAL SPO2 FINGERTIP SENSOR
Original Applicant
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki,  FI fin-00510
Original Contact tommi jokiniemi
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/06/2010
Decision Date 10/04/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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