FDA 510(k)

Fluorescence Mode

K-Number: K171007 · 2018-05-03

Decision Date2018-05-03

Product CodeNBL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Fluorescence Mode is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2018-05-03 under 510(k) number K171007. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fluorescence Mode?

Fluorescence Mode is a medical device that received FDA 510(k) clearance on 2018-05-03. The listed applicant is Carl Zeiss Suzhou Co., Ltd.. The 510(k) number is K171007.

When did Fluorescence Mode receive FDA 510(k) clearance?

Fluorescence Mode received FDA 510(k) clearance on 2018-05-03, under 510(k) number K171007.

Who is the listed applicant for Fluorescence Mode?

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

What is the FDA product code for Fluorescence Mode?

The FDA product code for Fluorescence Mode is NBL.

Other records listing Carl Zeiss Suzhou 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.

K163195PRIMUS

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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.