510(k) K180001

Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant by Embla Systems — Product Code MNR

K180001 is an FDA 510(k) premarket notification submitted by Embla Systems for the device "Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant". The FDA issued a decision of Substantially Equivalent on September 27, 2019. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Embla Systems has at least 8 other 510(k) clearances on record.