Name: Predicase
Price: 199 USD

K-number	K180001
Device name	Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
Applicant	Embla Systems
Product code	MNR
Device class	Class II
Decision date	Sep 27, 2019
Decision	Substantially Equivalent
Regulation	868.2375

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant

Everything you need for a 510(k) submission. Nothing you don't.