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FDA 510(k)

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono

K-Number: K232174 · 2024-02-23

ApplicantGenoss Co., Ltd.
Decision Date2024-02-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K232174. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono?

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K232174.

When did rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono receive FDA 510(k) clearance?

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono received FDA 510(k) clearance on 2024-02-23, under 510(k) number K232174.

Who is the listed applicant for rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono?

The FDA 510(k) record lists Genoss Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono?

The FDA product code for rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is EIH.

Other records listing Genoss Co., Ltd. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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