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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 K213463
Device Name NightOwl
Applicant
Ectosense nv
Bosbessenlaan 19 A
Rotselaar,  BE 3110
Applicant Contact Bart Van Pee
Correspondent
Ectosense nv
Bosbessenlaan 19 A
Rotselaar,  BE 3110
Correspondent Contact Bart Van Pee
Regulation Number868.2375
Classification Product Code
MNR  
Date Received10/27/2021
Decision Date 12/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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