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FDA 510(k) Applications Submitted by Embla Systems
FDA 510(k) Number
Submission Date
Device Name
Applicant
K122516
08/17/2012
EMBLETTA MPR
EMBLA SYSTEMS
K111742
06/21/2011
MDRIVE
EMBLA SYSTEMS
K180001
01/02/2018
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
Embla Systems
K172703
09/07/2017
Disposable Snap Electrode
Embla Systems
K173793
12/14/2017
XactTrace Single Use Respiratory Effort Belt System
Embla Systems
K163617
12/22/2016
REMbrandt
Embla Systems
K162140
08/01/2016
RemLogic
EMBLA SYSTEMS
K153353
11/20/2015
SANDMAN ELITE
EMBLA SYSTEMS
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