FDA 510(k)

Chuveiro Duplo de Seio Annabella (ADO-US23-1000)

Número K: K241506 · 2024-06-27

Data da decisão2024-06-27

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Annabella Double Breast Pump (ADO-US23-1000) is the device name listed in this FDA 510(k) record. The listed applicant is Annabella Tech. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K241506. 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 Annabella Double Breast Pump (ADO-US23-1000)?

Annabella Double Breast Pump (ADO-US23-1000) is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Annabella Tech. The 510(k) number is K241506.

When did Annabella Double Breast Pump (ADO-US23-1000) receive FDA 510(k) clearance?

Annabella Double Breast Pump (ADO-US23-1000) received FDA 510(k) clearance on 2024-06-27, under 510(k) number K241506.

Who is the listed applicant for Annabella Double Breast Pump (ADO-US23-1000)?

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

What is the FDA product code for Annabella Double Breast Pump (ADO-US23-1000)?

The FDA product code for Annabella Double Breast Pump (ADO-US23-1000) is HGX.

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