FDA 510(k)

ReDS System

Número K: K180479 · 2019-02-28

RequerenteSensible Medical Innovations , Ltd.

Data da decisão2019-02-28

Código do produtoDSB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ReDS System is the device name listed in this FDA 510(k) record. The listed applicant is Sensible Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2019-02-28 under 510(k) number K180479. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ReDS System?

ReDS System is a medical device that received FDA 510(k) clearance on 2019-02-28. The listed applicant is Sensible Medical Innovations , Ltd.. The 510(k) number is K180479.

When did ReDS System receive FDA 510(k) clearance?

ReDS System received FDA 510(k) clearance on 2019-02-28, under 510(k) number K180479.

Who is the listed applicant for ReDS System?

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

What is the FDA product code for ReDS System?

The FDA product code for ReDS System is DSB.

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Fonte oficial

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