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FDA 510(k)

Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)

Número K: K260346 · 2026-06-12

RequerentePolybell (Guangzhou) Limited
Data da decisão2026-06-12
Código do produtoHGX
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) is the device name listed in this FDA 510(k) record. The listed applicant is Polybell (Guangzhou) Limited. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K260346. 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 Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)?

Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Polybell (Guangzhou) Limited. The 510(k) number is K260346.

When did Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) receive FDA 510(k) clearance?

Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K260346.

Who is the listed applicant for Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)?

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

What is the FDA product code for Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)?

The FDA product code for Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) 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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