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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 a medical device manufactured by Genoss Co., Ltd.. It received FDA 510(k) clearance on 2024-02-23 under approval 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. It is manufactured by Genoss Co., Ltd.. The 510(k) number is K232174.

When was rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono approved by the FDA?

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

What company makes rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono?

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is manufactured by Genoss Co., Ltd..

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.

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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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