FDA 510(k)

Konan Specular Microscope XVII

K-Number: K191558 · 2020-03-26

Decision Date2020-03-26

Product CodeNQE

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Konan Specular Microscope XVII is the device name listed in this FDA 510(k) record. The listed applicant is Konan Medical, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K191558. The device is classified under product code NQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Konan Specular Microscope XVII?

Konan Specular Microscope XVII is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Konan Medical, Inc.. The 510(k) number is K191558.

When did Konan Specular Microscope XVII receive FDA 510(k) clearance?

Konan Specular Microscope XVII received FDA 510(k) clearance on 2020-03-26, under 510(k) number K191558.

Who is the listed applicant for Konan Specular Microscope XVII?

The FDA 510(k) record lists Konan Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Konan Specular Microscope XVII?

The FDA product code for Konan Specular Microscope XVII is NQE.

Other records listing Konan Medical, Inc. 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.

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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.