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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 K250874
Device Name Sunrise
Applicant
Sunrise SA
Chaussée De Marche, 598/02
Namur,  BE 5101
Applicant Contact Grégoire Lejeune
Correspondent
Sunrise SA
Chaussée De Marche, 598/02
Namur,  BE 5101
Correspondent Contact Grégoire Lejeune
Classification Product Code
QRS  
Date Received03/24/2025
Decision Date 08/29/2025
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
Predetermined Change
Control Plan Authorized		 No
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