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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 the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Bio Newvision Medical Equipment , Ltd.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) 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. The listed applicant is Chongqing Bio Newvision Medical Equipment , Ltd.. The 510(k) number is K190954.

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

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

Who is the listed applicant for Fundus Camera?

The FDA 510(k) record lists Chongqing Bio Newvision Medical Equipment , 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.

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve 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.

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