Fundus Camera— 510(k) K202097

Substantially Equivalent

Huvitz Co., Ltd.

FDA 510(k) clearance K202097 for Fundus Camera, Substantially Equivalent on 2021-02-02. Applicant: Huvitz Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huvitz Co., Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2020-07-29
Decision date: 2021-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.