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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 K913790
Device Name SENSORMEDICS OXYSHUTTLE II(TM)
Original Applicant
SENSORMEDICS CORP.
22705 savi ranch pkwy.
yorba linda,  CA  92887 4645
Original Contact david m trueblood
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/23/1991
Decision Date 02/26/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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