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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cranial electrotherapy stimulator to treat insomnia and/or anxiety
510(k) Number K230826
Device Name Modius Sleep
Applicant
Neurovalens Ltd.
8 Carmagrim Road
Portglenone,  GB BT44 8BP
Applicant Contact Jason McKeown
Correspondent
Neurovalens Ltd.
8 Carmagrim Road
Portglenone,  GB BT44 8BP
Correspondent Contact Jason McKeown
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received03/24/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT04595968
Reviewed by Third Party No
Combination Product No
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