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FDA 510(k)

Powered Breast Pump (Models 7V and 7X)

Número K: K211016 · 2022-06-29

RequerenteHaenim Co., Ltd.
Data da decisão2022-06-29
Código do produtoHGX
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Powered Breast Pump (Models 7V and 7X) is the device name listed in this FDA 510(k) record. The listed applicant is Haenim Co., Ltd.. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K211016. 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 Powered Breast Pump (Models 7V and 7X)?

Powered Breast Pump (Models 7V and 7X) is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Haenim Co., Ltd.. The 510(k) number is K211016.

When did Powered Breast Pump (Models 7V and 7X) receive FDA 510(k) clearance?

Powered Breast Pump (Models 7V and 7X) received FDA 510(k) clearance on 2022-06-29, under 510(k) number K211016.

Who is the listed applicant for Powered Breast Pump (Models 7V and 7X)?

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

What is the FDA product code for Powered Breast Pump (Models 7V and 7X)?

The FDA product code for Powered Breast Pump (Models 7V and 7X) is HGX.

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Dispositivos Relacionados (Código: HGX)

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Fonte oficial

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