FDA 510(k)

Harioculture TL-16 Time-lapse Incubator

Número K: K242684 · 2025-05-22

RequerenteHua Yue Medical Technology Co., Ltd.

Data da decisão2025-05-22

Código do produtoMQG

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Harioculture TL-16 Time-lapse Incubator is the device name listed in this FDA 510(k) record. The listed applicant is Hua Yue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K242684. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Harioculture TL-16 Time-lapse Incubator?

Harioculture TL-16 Time-lapse Incubator is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Hua Yue Medical Technology Co., Ltd.. The 510(k) number is K242684.

When did Harioculture TL-16 Time-lapse Incubator receive FDA 510(k) clearance?

Harioculture TL-16 Time-lapse Incubator received FDA 510(k) clearance on 2025-05-22, under 510(k) number K242684.

Who is the listed applicant for Harioculture TL-16 Time-lapse Incubator?

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

What is the FDA product code for Harioculture TL-16 Time-lapse Incubator?

The FDA product code for Harioculture TL-16 Time-lapse Incubator is MQG.

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Fonte oficial

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