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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 K132696
Device Name TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
Applicant
GE HEALTHCARE FINLAND OY
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Applicant Contact JOEL KENT
Correspondent
GE HEALTHCARE FINLAND OY
86 PILGRIM ROAD
NEEDHAM,  MA  02492
Correspondent Contact JOEL KENT
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/29/2013
Decision Date 09/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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