FDA 510(k)

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

Número K: K170304 · 2018-03-02

Data da decisão2018-03-02

Código do produtoFLE

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is the device name listed in this FDA 510(k) record. The listed applicant is Astell Scientific Limited. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K170304. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Astell Scientific Limited. The 510(k) number is K170304.

When did Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers receive FDA 510(k) clearance?

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers received FDA 510(k) clearance on 2018-03-02, under 510(k) number K170304.

Who is the listed applicant for Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?

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

What is the FDA product code for Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers?

The FDA product code for Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers is FLE.

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