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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device for sleep apnea testing based on mandibular movement
510(k) Number K222262
Device Name Sunrise
Sunrise SA
Chaussee de Marche 598/02
Namur,  BE 5101
Applicant Contact Gregoire Lejeune
Sunrise SA
Chaussee de Marche 598/02
Namur,  BE 5101
Correspondent Contact Gregoire Lejeune
Regulation Number868.2376
Classification Product Code
Date Received07/28/2022
Decision Date 12/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No