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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 K191031
Device Name NightOwl
Applicant
Ectosense NV
Bosbessenlaan 19a
Rotselaar,  BE 3110
Applicant Contact Bart Van Pee
Correspondent
Ectosense NV
Bosbessenlaan 19a
Rotselaar,  BE 3110
Correspondent Contact Bart Van Pee
Regulation Number868.2375
Classification Product Code
MNR  
Date Received04/18/2019
Decision Date 03/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT03774199
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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