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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
Applicant
GE HealthCare Finland OY
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Applicant Contact TOMMI JOKINIEMI
Correspondent
GE HealthCare Finland OY
Kuortaneenkatu 2
Helsinki,  FI FIN-00510
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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