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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
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