Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Embla Systems

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

Total Devices6
Categories3
Latest FDA decision2019-09-27
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
↑