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Embla Systems

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest Approval2019-09-27
TypeNumberDevice NameCodeDate
510(k) K180001 Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant MNR 2019-09-27 View
510(k) K173793 XactTrace Single Use Respiratory Effort Belt System MNR 2019-03-01 View
510(k) K172703 Disposable Snap Electrode GXY 2017-11-13 View
510(k) K163617 REMbrandt OLZ 2017-04-11 View
510(k) K162140 RemLogic OLZ 2016-12-01 View
510(k) K153353 SANDMAN ELITE OLZ 2016-06-23 View