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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 K121912
Device Name E1 EAR SENSORS
Original Applicant
40 parker
irvine,  CA  92618
Original Contact david collette
Regulation Number870.2700
Classification Product Code
Date Received07/02/2012
Decision Date 07/24/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No