FDA 510(k)

Fundus Camera

K-Number: K202097 · 2021-02-02

Decision Date2021-02-02

Product CodeHKI

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Fundus Camera is the device name listed in this FDA 510(k) record. The listed applicant is Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2021-02-02 under 510(k) number K202097. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fundus Camera?

Fundus Camera is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is Huvitz Co., Ltd.. The 510(k) number is K202097.

When did Fundus Camera receive FDA 510(k) clearance?

Fundus Camera received FDA 510(k) clearance on 2021-02-02, under 510(k) number K202097.

Who is the listed applicant for Fundus Camera?

The FDA 510(k) record lists Huvitz Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fundus Camera?

The FDA product code for Fundus Camera is HKI.

Other records listing Huvitz Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232143Applanation Tonometer HT-5000 K191615Huvitz Imaging System K161829Huvitz Imaging System

Related Devices (Code: HKI)

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom Technologies K252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited K250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.Ltd K250683Resolve Fundus CameraOptain Health, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.