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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
Applicant
NEUROPHET, Inc.
12F, 124, Teheran-ro, Gangnam-gu
Seoul,  KR
Applicant Contact Boreum Yoo
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave. STE 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
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
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