FDA 510(k)

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube

Número K: K173384 · 2018-04-10

Data da decisão2018-04-10

Código do produtoBTO

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Ads, Inc.. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K173384. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube?

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Smiths Medical Ads, Inc.. The 510(k) number is K173384.

When did BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube receive FDA 510(k) clearance?

BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube received FDA 510(k) clearance on 2018-04-10, under 510(k) number K173384.

Who is the listed applicant for BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube?

The FDA 510(k) record lists Smiths Medical Ads, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube?

The FDA product code for BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube is BTO.

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Dispositivos Relacionados (Código: BTO)

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Fonte oficial

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