FDA 510(k)

Pump In Style Advanced, Advanced Personal Double Breastpump

Número K: K181937 · 2018-10-16

Data da decisão2018-10-16

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pump In Style Advanced, Advanced Personal Double Breastpump is the device name listed in this FDA 510(k) record. The listed applicant is Medela, LLC. It received FDA 510(k) clearance on 2018-10-16 under 510(k) number K181937. 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 Pump In Style Advanced, Advanced Personal Double Breastpump?

Pump In Style Advanced, Advanced Personal Double Breastpump is a medical device that received FDA 510(k) clearance on 2018-10-16. The listed applicant is Medela, LLC. The 510(k) number is K181937.

When did Pump In Style Advanced, Advanced Personal Double Breastpump receive FDA 510(k) clearance?

Pump In Style Advanced, Advanced Personal Double Breastpump received FDA 510(k) clearance on 2018-10-16, under 510(k) number K181937.

Who is the listed applicant for Pump In Style Advanced, Advanced Personal Double Breastpump?

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

What is the FDA product code for Pump In Style Advanced, Advanced Personal Double Breastpump?

The FDA product code for Pump In Style Advanced, Advanced Personal Double Breastpump is HGX.

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Outros registros que listam Medela, LLC como candidato(a)

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Dispositivos Relacionados (Código: HGX)

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Fonte oficial

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