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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K202097
Device Name Fundus Camera
Huvitz Co., Ltd.
38, 170 Beon-Gil, Dongan-Gu
Anyang-Si,  KR 14055
Applicant Contact Hyung Min Heo
Mtech Group
7707 Fannin St. Ste 200
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number886.1120
Classification Product Code
Date Received07/29/2020
Decision Date 02/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No