FDA 510(k)

Wearable Breast Pump (Model S10)

Número K: K220309 · 2022-06-27

RequerenteShenzhen Lutejiacheng Technology Co., Ltd.

Data da decisão2022-06-27

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wearable Breast Pump (Model S10) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lutejiacheng Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-27 under 510(k) number K220309. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wearable Breast Pump (Model S10)?

Wearable Breast Pump (Model S10) is a medical device that received FDA 510(k) clearance on 2022-06-27. The listed applicant is Shenzhen Lutejiacheng Technology Co., Ltd.. The 510(k) number is K220309.

When did Wearable Breast Pump (Model S10) receive FDA 510(k) clearance?

Wearable Breast Pump (Model S10) received FDA 510(k) clearance on 2022-06-27, under 510(k) number K220309.

Who is the listed applicant for Wearable Breast Pump (Model S10)?

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

What is the FDA product code for Wearable Breast Pump (Model S10)?

The FDA product code for Wearable Breast Pump (Model S10) is HGX.

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Outros registros que listam Shenzhen Lutejiacheng Technology Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: HGX)

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Fonte oficial

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