FDA 510(k)

BD MAX CT/GC/TV, BD MAX INSTRUMENT

Número K: K151589 · 2016-09-06

Data da decisão2016-09-06

Código do produtoOUY

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD MAX CT/GC/TV, BD MAX INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K151589. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD MAX CT/GC/TV, BD MAX INSTRUMENT?

BD MAX CT/GC/TV, BD MAX INSTRUMENT is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K151589.

When did BD MAX CT/GC/TV, BD MAX INSTRUMENT receive FDA 510(k) clearance?

BD MAX CT/GC/TV, BD MAX INSTRUMENT received FDA 510(k) clearance on 2016-09-06, under 510(k) number K151589.

Who is the listed applicant for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT?

The FDA product code for BD MAX CT/GC/TV, BD MAX INSTRUMENT is OUY.

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Fonte oficial

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