FDA 510(k)

Youmagic FLM System (YM5-U1)

Número K: K240857 · 2025-05-15

RequerenteWe Medical Technology (Wuxi) Co., Ltd.

Data da decisão2025-05-15

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Youmagic FLM System (YM5-U1) is the device name listed in this FDA 510(k) record. The listed applicant is We Medical Technology (Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K240857. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Youmagic FLM System (YM5-U1)?

Youmagic FLM System (YM5-U1) is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is We Medical Technology (Wuxi) Co., Ltd.. The 510(k) number is K240857.

When did Youmagic FLM System (YM5-U1) receive FDA 510(k) clearance?

Youmagic FLM System (YM5-U1) received FDA 510(k) clearance on 2025-05-15, under 510(k) number K240857.

Who is the listed applicant for Youmagic FLM System (YM5-U1)?

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

What is the FDA product code for Youmagic FLM System (YM5-U1)?

The FDA product code for Youmagic FLM System (YM5-U1) is GEI.

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