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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 K253668
Device Name Onera SleepMap (SLEEPMAP)
Applicant
Onera B.V.
Torenallee 42-54
Eindhoven,  NL 5617BD
Applicant Contact Pieter Ermers
Correspondent
Onera B.V.
Torenallee 42-54
Eindhoven,  NL 5617BD
Correspondent Contact Pieter Ermers
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received11/21/2025
Decision Date 03/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Clinical Trials NCT05310708
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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