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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilatory effort recorder
510(k) Number K180001
Device Name Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
Embla Systems
1 Hines Road
Suite 202
Kanata,  CA K2K 3C7
Applicant Contact Sanjay Mehta
Embla Systems
1 Hines Road
Suite 202
Kanata,  CA K2K 3C7
Correspondent Contact Sanjay Mehta
Regulation Number868.2375
Classification Product Code
Subsequent Product Code
Date Received01/02/2018
Decision Date 09/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No