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FDA 510(k)

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)

K-Number: K231075 · 2023-06-20

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2023-06-20
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) is a medical device manufactured by Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2023-06-20 under approval number K231075. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)?

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Carl Zeiss Meditec, Inc.. The 510(k) number is K231075.

When was Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) approved by the FDA?

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) received FDA 510(k) clearance on 2023-06-20, under approval number K231075.

What company makes Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)?

Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) is manufactured by Carl Zeiss Meditec, Inc..

What is the FDA product code for Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)?

The FDA product code for Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) is IZI.

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Related Devices (Code: IZI)

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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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