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FDA 510(k)

Legend X Platform

K-Number: K232903 · 2023-10-17

ApplicantPollogen, Ltd.
Decision Date2023-10-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Legend X Platform is a medical device manufactured by Pollogen, Ltd.. It received FDA 510(k) clearance on 2023-10-17 under approval number K232903. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Legend X Platform?

Legend X Platform is a medical device that received FDA 510(k) clearance on 2023-10-17. It is manufactured by Pollogen, Ltd.. The 510(k) number is K232903.

When was Legend X Platform approved by the FDA?

Legend X Platform received FDA 510(k) clearance on 2023-10-17, under approval number K232903.

What company makes Legend X Platform?

Legend X Platform is manufactured by Pollogen, Ltd..

What is the FDA product code for Legend X Platform?

The FDA product code for Legend X Platform is GEI.

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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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