FDA 510(k)

Sistema de Controle de Fluxo Aquilex AQL-100S

Número K: K172040 · 2018-02-05

Data da decisão2018-02-05

Código do produtoHIG

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aquilex Fluid Control System AQL-100S is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K172040. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aquilex Fluid Control System AQL-100S?

Aquilex Fluid Control System AQL-100S is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K172040.

When did Aquilex Fluid Control System AQL-100S receive FDA 510(k) clearance?

Aquilex Fluid Control System AQL-100S received FDA 510(k) clearance on 2018-02-05, under 510(k) number K172040.

Who is the listed applicant for Aquilex Fluid Control System AQL-100S?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquilex Fluid Control System AQL-100S?

The FDA product code for Aquilex Fluid Control System AQL-100S is HIG.

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