FDA 510(k)

Lacevo Wearable Breast Pump (Model S70)

Número K: K250829 · 2025-04-17

RequerenteShenzhen TPH Technology Co., Ltd.

Data da decisão2025-04-17

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lacevo Wearable Breast Pump (Model S70) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen TPH Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-17 under 510(k) number K250829. 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 Lacevo Wearable Breast Pump (Model S70)?

Lacevo Wearable Breast Pump (Model S70) is a medical device that received FDA 510(k) clearance on 2025-04-17. The listed applicant is Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K250829.

When did Lacevo Wearable Breast Pump (Model S70) receive FDA 510(k) clearance?

Lacevo Wearable Breast Pump (Model S70) received FDA 510(k) clearance on 2025-04-17, under 510(k) number K250829.

Who is the listed applicant for Lacevo Wearable Breast Pump (Model S70)?

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

What is the FDA product code for Lacevo Wearable Breast Pump (Model S70)?

The FDA product code for Lacevo Wearable Breast Pump (Model S70) is HGX.

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

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Dispositivos Relacionados (Código: HGX)

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Fonte oficial

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