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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 K233438
Device Name SleepStageML
Applicant
Beacon Biosignals, Inc.
22 Boston Wharf Road
7th Floor, Unit 41
Boston,  MA  02210
Applicant Contact Delphine Lemoine
Correspondent
Beacon Biosignals, Inc.
22 Boston Wharf Road
7th Floor, Unit 41
Boston,  MA  02210
Correspondent Contact Delphine Lemoine
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received10/13/2023
Decision Date 03/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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