FDA 510(k)

Plexus

Número K: K191107 · 2019-08-27

Data da decisão2019-08-27

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Plexus is the device name listed in this FDA 510(k) record. The listed applicant is Alleva Medical (D.G), Ltd.. It received FDA 510(k) clearance on 2019-08-27 under 510(k) number K191107. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Plexus?

Plexus is a medical device that received FDA 510(k) clearance on 2019-08-27. The listed applicant is Alleva Medical (D.G), Ltd.. The 510(k) number is K191107.

When did Plexus receive FDA 510(k) clearance?

Plexus received FDA 510(k) clearance on 2019-08-27, under 510(k) number K191107.

Who is the listed applicant for Plexus?

The FDA 510(k) record lists Alleva Medical (D.G), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Plexus?

The FDA product code for Plexus is JOW.

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