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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K220437
Device Name Neurophet AQUA
12F, 124, Teheran-ro, Gangnam-gu
Seoul,  KR
Applicant Contact Boreum Yoo
LK Consulting Group USA, Inc.
18881 Von Karman Ave. STE 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
Date Received02/16/2022
Decision Date 05/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No