Fundus Camera

Camera, Ophthalmic, Ac-powered

Huvitz Co., Ltd.

The following data is part of a premarket notification filed by Huvitz Co., Ltd. with the FDA for Fundus Camera.

Pre-market Notification Details

Device IDK202097
510k NumberK202097
Device Name:Fundus Camera
ClassificationCamera, Ophthalmic, Ac-powered
Applicant Huvitz Co., Ltd. 38, 170 Beon-Gil, Dongan-Gu Anyang-si,  KR 14055
ContactHyung Min Heo
CorrespondentDave Kim
Mtech Group 7707 Fannin St. Ste 200 Houston,  TX  77054
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-29
Decision Date2021-02-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800019600541 K202097 000

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