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FDA 510(k)

YELLOW 560 Fluorescence Module

K-Number: K162991 · 2017-07-24

Decision Date2017-07-24
Product CodeIZI
Advisory CommitteeRA
DecisionUnknown

Device Summary

YELLOW 560 Fluorescence Module is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2017-07-24 under 510(k) number K162991. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the YELLOW 560 Fluorescence Module?

YELLOW 560 Fluorescence Module is a medical device that received FDA 510(k) clearance on 2017-07-24. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K162991.

When did YELLOW 560 Fluorescence Module receive FDA 510(k) clearance?

YELLOW 560 Fluorescence Module received FDA 510(k) clearance on 2017-07-24, under 510(k) number K162991.

Who is the listed applicant for YELLOW 560 Fluorescence Module?

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

What is the FDA product code for YELLOW 560 Fluorescence Module?

The FDA product code for YELLOW 560 Fluorescence Module is IZI.

Related Clinical Trials

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.

Other records listing Carl Zeiss Meditec, AG 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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Related Devices (Code: IZI)

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.

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.