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FDA 510(k)

RCT600

K-Number: K243903 · 2025-03-12

ApplicantRay Co., Ltd.
Decision Date2025-03-12
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RCT600 is a medical device manufactured by Ray Co., Ltd.. It received FDA 510(k) clearance on 2025-03-12 under approval number K243903. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RCT600?

RCT600 is a medical device that received FDA 510(k) clearance on 2025-03-12. It is manufactured by Ray Co., Ltd.. The 510(k) number is K243903.

When was RCT600 approved by the FDA?

RCT600 received FDA 510(k) clearance on 2025-03-12, under approval number K243903.

What company makes RCT600?

RCT600 is manufactured by Ray Co., Ltd..

What is the FDA product code for RCT600?

The FDA product code for RCT600 is OAS.

Other Devices by Ray Co., Ltd.

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Related Devices (Code: OAS)

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.