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FDA 510(k)

Wearable breast pump

Número K: K221598 · 2022-12-09

RequerenteMayborn (Uk) Limited
Data da decisão2022-12-09
Código do produtoHGX
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Wearable breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Mayborn (Uk) Limited. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K221598. 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?

Wearable breast pump is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Mayborn (Uk) Limited. The 510(k) number is K221598.

When did Wearable breast pump receive FDA 510(k) clearance?

Wearable breast pump received FDA 510(k) clearance on 2022-12-09, under 510(k) number K221598.

Who is the listed applicant for Wearable breast pump?

The FDA 510(k) record lists Mayborn (Uk) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable breast pump?

The FDA product code for Wearable breast pump is HGX.

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Dispositivos Relacionados (Código: HGX)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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