Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant— 510(k) K180001
Substantially EquivalentEmbla Systems
FDA 510(k) clearance K180001 for Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant, Substantially Equivalent on 2019-09-27. Applicant: Embla Systems.
Clearance details
- Applicant
- Embla Systems
- Product code
- Code MNR
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Kanata, CA
Data sourced from openFDA. This site is unofficial and independent of the FDA.