FDA 510(k)

Spirobank Oxi

Número K: K230501 · 2023-12-15

RequerenteMir Medical International Research USA

Data da decisão2023-12-15

Código do produtoBZG

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spirobank Oxi is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical International Research USA. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K230501. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spirobank Oxi?

Spirobank Oxi is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Mir Medical International Research USA. The 510(k) number is K230501.

When did Spirobank Oxi receive FDA 510(k) clearance?

Spirobank Oxi received FDA 510(k) clearance on 2023-12-15, under 510(k) number K230501.

Who is the listed applicant for Spirobank Oxi?

The FDA 510(k) record lists Mir Medical International Research USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spirobank Oxi?

The FDA product code for Spirobank Oxi is BZG.

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