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FDA 510(k)

Limbus Contour

K-Number: K201232 · 2020-08-13

ApplicantLimbus Ai, Inc.
Decision Date2020-08-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Limbus Contour is a medical device manufactured by Limbus Ai, Inc.. It received FDA 510(k) clearance on 2020-08-13 under approval number K201232. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Limbus Contour?

Limbus Contour is a medical device that received FDA 510(k) clearance on 2020-08-13. It is manufactured by Limbus Ai, Inc.. The 510(k) number is K201232.

When was Limbus Contour approved by the FDA?

Limbus Contour received FDA 510(k) clearance on 2020-08-13, under approval number K201232.

What company makes Limbus Contour?

Limbus Contour is manufactured by Limbus Ai, Inc..

What is the FDA product code for Limbus Contour?

The FDA product code for Limbus Contour is LLZ.

Other Devices by Limbus Ai, Inc.

K230575Limbus Contour K241837Limbus Contour

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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.

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