FDA 510(k)

RT-Mind-AI

Número K: K213155 · 2021-12-15

Data da decisão2021-12-15

Código do produtoQKB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

RT-Mind-AI is the device name listed in this FDA 510(k) record. The listed applicant is Medmind Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K213155. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RT-Mind-AI?

RT-Mind-AI is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Medmind Technology Co., Ltd.. The 510(k) number is K213155.

When did RT-Mind-AI receive FDA 510(k) clearance?

RT-Mind-AI received FDA 510(k) clearance on 2021-12-15, under 510(k) number K213155.

Who is the listed applicant for RT-Mind-AI?

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

What is the FDA product code for RT-Mind-AI?

The FDA product code for RT-Mind-AI is QKB.

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