FDA 510(k)

Alio Medical Remote Monitoring System

Número K: K211365 · 2022-03-24

Data da decisão2022-03-24

Código do produtoDRG

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Alio Medical Remote Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Graftworx, Inc. Dba Alio. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K211365. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Alio Medical Remote Monitoring System?

Alio Medical Remote Monitoring System is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Graftworx, Inc. Dba Alio. The 510(k) number is K211365.

When did Alio Medical Remote Monitoring System receive FDA 510(k) clearance?

Alio Medical Remote Monitoring System received FDA 510(k) clearance on 2022-03-24, under 510(k) number K211365.

Who is the listed applicant for Alio Medical Remote Monitoring System?

The FDA 510(k) record lists Graftworx, Inc. Dba Alio as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alio Medical Remote Monitoring System?

The FDA product code for Alio Medical Remote Monitoring System is DRG.

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