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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K220056
Device Name iSyncWave
Applicant
iMediSync Inc.
3rd FL. 175 Yeoksam-ro, Gangnam-gu
Seoul,  KR 06247
Applicant Contact Seung Wan Kang
Correspondent
iMediSync Inc.
3rd FL. 175 Yeoksam-ro, Gangnam-gu
Seoul,  KR 06247
Correspondent Contact Young-Geun Kim
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GXY  
Date Received01/06/2022
Decision Date 08/10/2022
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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