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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
Applicant
Huvitz Co., Ltd.
38, 170 Beon-Gil, Dongan-Gu
Anyang-Si,  KR 14055
Applicant Contact Hyung Min Heo
Correspondent
Mtechgroup
7707 Fannin St. Suite 200
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number886.1120
Classification Product Code
HKI  
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
Predetermined Change
Control Plan Authorized		 No
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