Embla Systems is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Embla Systems - FDA 510(k) Cleared Devices
Recent clearances: Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant, XactTrace Single Use Respiratory Effort Belt System
8
Total
8
Cleared
0
Denied
Embla Systems has 8 FDA 510(k) cleared medical devices. Based in Thornton, US.
Historical record: 8 cleared submissions from 2011 to 2019. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Embla Systems Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Embla Systems
8 devices
Cleared
Sep 27, 2019
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child,...
Anesthesiology
633d
Cleared
Mar 01, 2019
XactTrace Single Use Respiratory Effort Belt System
Anesthesiology
442d
Cleared
Nov 13, 2017
Disposable Snap Electrode
Neurology
67d
Cleared
Apr 11, 2017
REMbrandt
Neurology
110d
Cleared
Dec 01, 2016
RemLogic
Neurology
122d
Cleared
Jun 23, 2016
SANDMAN ELITE
Neurology
216d
Cleared
Feb 21, 2013
EMBLETTA MPR
Anesthesiology
188d
Cleared
Aug 31, 2011
MDRIVE
Anesthesiology
71d