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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 K242094
Device Name Dreem 3S
Applicant
Beacon Biosignals, Inc.
22 Boston Wharf Road
7th Floor, Unit 41
Boston,  MA  02210
Applicant Contact Alexander Chan
Correspondent
Beacon Biosignals, Inc.
22 Boston Wharf Road
7th Floor, Unit 41
Boston,  MA  02210
Correspondent Contact Alexander Chan
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
OLV  
Date Received07/17/2024
Decision Date 11/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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