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FDA 510(k)

Fundus Camera

K-Number: K202097 · 2021-02-02

ApplicantHuvitz Co., Ltd.
Decision Date2021-02-02
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Fundus Camera is a medical device manufactured by Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2021-02-02 under approval 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. It is manufactured by Huvitz Co., Ltd.. The 510(k) number is K202097.

When was Fundus Camera approved by the FDA?

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

What company makes Fundus Camera?

Fundus Camera is manufactured by Huvitz Co., Ltd..

What is the FDA product code for Fundus Camera?

The FDA product code for Fundus Camera is HKI.

Other Devices by Huvitz Co., Ltd.

K161829Huvitz Imaging System K191615Huvitz Imaging System K232143Applanation Tonometer HT-5000

Related Devices (Code: HKI)

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Official Source

View on FDA Database →

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

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