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FDA 510(k)

PlaDuo System

K-Number: K232223 · 2023-10-24

ApplicantShenB Co., Ltd.
Decision Date2023-10-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PlaDuo System is a medical device manufactured by ShenB Co., Ltd.. It received FDA 510(k) clearance on 2023-10-24 under approval number K232223. 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 PlaDuo System?

PlaDuo System is a medical device that received FDA 510(k) clearance on 2023-10-24. It is manufactured by ShenB Co., Ltd.. The 510(k) number is K232223.

When was PlaDuo System approved by the FDA?

PlaDuo System received FDA 510(k) clearance on 2023-10-24, under approval number K232223.

What company makes PlaDuo System?

PlaDuo System is manufactured by ShenB Co., Ltd..

What is the FDA product code for PlaDuo System?

The FDA product code for PlaDuo System is GEI.

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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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