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FDA 510(k)

RAYDENT SW

K-Number: K233625 · 2024-05-16

ApplicantRay Co., Ltd.
Decision Date2024-05-16
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RAYDENT SW is a medical device manufactured by Ray Co., Ltd.. It received FDA 510(k) clearance on 2024-05-16 under approval number K233625. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAYDENT SW?

RAYDENT SW is a medical device that received FDA 510(k) clearance on 2024-05-16. It is manufactured by Ray Co., Ltd.. The 510(k) number is K233625.

When was RAYDENT SW approved by the FDA?

RAYDENT SW received FDA 510(k) clearance on 2024-05-16, under approval number K233625.

What company makes RAYDENT SW?

RAYDENT SW is manufactured by Ray Co., Ltd..

What is the FDA product code for RAYDENT SW?

The FDA product code for RAYDENT SW is PNN.

Other Devices by Ray Co., Ltd.

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Related Devices (Code: PNN)

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.