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FDA 510(k)

2430TCA with Xmaru W

K-Number: K243849 · 2025-03-12

Decision Date2025-03-12
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

2430TCA with Xmaru W is a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2025-03-12 under approval number K243849. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2430TCA with Xmaru W?

2430TCA with Xmaru W is a medical device that received FDA 510(k) clearance on 2025-03-12. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K243849.

When was 2430TCA with Xmaru W approved by the FDA?

2430TCA with Xmaru W received FDA 510(k) clearance on 2025-03-12, under approval number K243849.

What company makes 2430TCA with Xmaru W?

2430TCA with Xmaru W is manufactured by Rayence Co., Ltd..

What is the FDA product code for 2430TCA with Xmaru W?

The FDA product code for 2430TCA with Xmaru W is MUE.

Other Devices by Rayence Co., Ltd.

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Related Devices (Code: MUE)

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.