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FDA 510(k)

Fundus Camera

K-Number: K190954 · 2020-01-22

ApplicantChongqing Bio Newvision Medical Equipment , Ltd.
Decision Date2020-01-22
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Fundus Camera is a medical device manufactured by Chongqing Bio Newvision Medical Equipment , Ltd.. It received FDA 510(k) clearance on 2020-01-22 under approval number K190954. 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 2020-01-22. It is manufactured by Chongqing Bio Newvision Medical Equipment , Ltd.. The 510(k) number is K190954.

When was Fundus Camera approved by the FDA?

Fundus Camera received FDA 510(k) clearance on 2020-01-22, under approval number K190954.

What company makes Fundus Camera?

Fundus Camera is manufactured by Chongqing Bio Newvision Medical Equipment , Ltd..

What is the FDA product code for Fundus Camera?

The FDA product code for Fundus Camera is 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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