FDA 510(k)

AirTom

Número K: K222466 · 2023-06-30

RequerenteBilab

Data da decisão2023-06-30

Código do produtoQEB

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

AirTom is the device name listed in this FDA 510(k) record. The listed applicant is Bilab. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K222466. The device is classified under product code QEB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AirTom?

AirTom is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Bilab. The 510(k) number is K222466.

When did AirTom receive FDA 510(k) clearance?

AirTom received FDA 510(k) clearance on 2023-06-30, under 510(k) number K222466.

Who is the listed applicant for AirTom?

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

What is the FDA product code for AirTom?

The FDA product code for AirTom is QEB.

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