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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Polysomnograph With Electroencephalograph
510(k) Number K223539
Device Name Dreem 3S
Applicant
Beacon Biosignals, Inc.
22 Boston Wharf Rd., 7th Floor, unit 41,
Boston,  MA  02210
Applicant Contact Delphine Lemoine
Correspondent
Beacon Biosignals, Inc
17-21 rue Saint-Fiacre
Paris,  FR 75002
Correspondent Contact Delphine Lemoine
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
OLV  
Date Received11/23/2022
Decision Date 08/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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