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FDA 510(k)

NubeX

K-Number: K211480 · 2021-07-08

ApplicantTechheim Co., Ltd.
Decision Date2021-07-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NubeX is a medical device manufactured by Techheim Co., Ltd.. It received FDA 510(k) clearance on 2021-07-08 under approval number K211480. 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 NubeX?

NubeX is a medical device that received FDA 510(k) clearance on 2021-07-08. It is manufactured by Techheim Co., Ltd.. The 510(k) number is K211480.

When was NubeX approved by the FDA?

NubeX received FDA 510(k) clearance on 2021-07-08, under approval number K211480.

What company makes NubeX?

NubeX is manufactured by Techheim Co., Ltd..

What is the FDA product code for NubeX?

The FDA product code for NubeX is LLZ.

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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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