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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 K223922
Device Name SOMNUM (V.1.1.2.)
Applicant
Honeynaps Co., Ltd.
4f, Marine Tech B/D, 529, Nonhyeon-Ro, Gangnam-Gu
Seoul,  KR 06126
Applicant Contact Tony Lee
Correspondent
Honeynaps Co., Ltd.
4f, Marine Tech B/D, 529, Nonhyeon-Ro, Gangnam-Gu
Seoul,  KR 06126
Correspondent Contact Tony Lee
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received12/30/2022
Decision Date 08/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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