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
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000
08800019600541 K202097 000

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