FDA 510(k)

FILTRAY 2G Disposable Water Filters

Número K: K191563 · 2019-10-25

Data da decisão2019-10-25

Código do produtoNHV

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

FILTRAY 2G Disposable Water Filters is the device name listed in this FDA 510(k) record. The listed applicant is Aqua-Tools. It received FDA 510(k) clearance on 2019-10-25 under 510(k) number K191563. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FILTRAY 2G Disposable Water Filters?

FILTRAY 2G Disposable Water Filters is a medical device that received FDA 510(k) clearance on 2019-10-25. The listed applicant is Aqua-Tools. The 510(k) number is K191563.

When did FILTRAY 2G Disposable Water Filters receive FDA 510(k) clearance?

FILTRAY 2G Disposable Water Filters received FDA 510(k) clearance on 2019-10-25, under 510(k) number K191563.

Who is the listed applicant for FILTRAY 2G Disposable Water Filters?

The FDA 510(k) record lists Aqua-Tools as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILTRAY 2G Disposable Water Filters?

The FDA product code for FILTRAY 2G Disposable Water Filters is NHV.

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