Embla Systems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor September 27, 2019
K173793XactTrace Single Use Respiratory Effort Belt SystemMarch 1, 2019
K172703Disposable Snap ElectrodeNovember 13, 2017
K163617REMbrandtApril 11, 2017
K162140RemLogicDecember 1, 2016
K153353SANDMAN ELITEJune 23, 2016
K122516EMBLETTA MPRFebruary 21, 2013
K111742MDRIVEAugust 31, 2011
K073682EMBLETTA GOLDAugust 8, 2008