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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 K862617
Device Name SENSORMEDICS OXYSHUTTLE(TM)
Original Applicant
SENSORMEDICS CORP.
1630 s. state college blvd.
anaheim,  CA  92806
Original Contact merton a robinson
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/09/1986
Decision Date 09/26/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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