FDA 510(k) Applications Submitted by Embla Systems

FDA 510(k) Number Submission Date Device Name Applicant
K122516 08/17/2012 EMBLETTA MPR EMBLA SYSTEMS
K111742 06/21/2011 MDRIVE EMBLA SYSTEMS
K180001 01/02/2018 Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant Embla Systems
K172703 09/07/2017 Disposable Snap Electrode Embla Systems
K173793 12/14/2017 XactTrace Single Use Respiratory Effort Belt System Embla Systems
K163617 12/22/2016 REMbrandt Embla Systems
K162140 08/01/2016 RemLogic EMBLA SYSTEMS
K153353 11/20/2015 SANDMAN ELITE EMBLA SYSTEMS


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