FDA 510(k)

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)

Номер K: K222727 · 2023-06-02

Дата решения2023-06-02

Код продуктаNHV

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is the device name listed in this FDA 510(k) record. The listed applicant is I3 Membrane GmbH. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K222727. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is I3 Membrane GmbH. The 510(k) number is K222727.

When did i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) receive FDA 510(k) clearance?

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) received FDA 510(k) clearance on 2023-06-02, under 510(k) number K222727.

Who is the listed applicant for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

The FDA 510(k) record lists I3 Membrane GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)?

The FDA product code for i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) is NHV.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: NHV)

K261470QF10E.A.M Benelux B.V K191563FILTRAY 2G Disposable Water FiltersAqua-Tools K182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower WandEcolab, Inc.K173164Ecolab POU Water FilterEcolab, Inc.K163609Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)Pall International Sarl K161467HydraGuard 10 UltraFilterNephros, Inc.

Официальный источник

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