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Embla Systems

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K180001 Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor InfantMNR2019-09-27 View
510(k) K173793 XactTrace Single Use Respiratory Effort Belt SystemMNR2019-03-01 View
510(k) K172703 Disposable Snap ElectrodeGXY2017-11-13 View
510(k) K163617 REMbrandtOLZ2017-04-11 View
510(k) K162140 RemLogicOLZ2016-12-01 View
510(k) K153353 SANDMAN ELITEOLZ2016-06-23 View
510(k) K122516 EMBLETTA MPRMNR2013-02-21 View
510(k) K111742 MDRIVEMNR2011-08-31 View
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