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510(k) K180001

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2019
Date Received
January 2, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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