FDA 510(k)

Aquadex FlexFlow System 2.0

Номер K: K192756 · 2020-02-24

Дата решения2020-02-24

Код продуктаKDI

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Aquadex FlexFlow System 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Chf Solutions, Inc.. It received FDA 510(k) clearance on 2020-02-24 under 510(k) number K192756. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Aquadex FlexFlow System 2.0?

Aquadex FlexFlow System 2.0 is a medical device that received FDA 510(k) clearance on 2020-02-24. The listed applicant is Chf Solutions, Inc.. The 510(k) number is K192756.

When did Aquadex FlexFlow System 2.0 receive FDA 510(k) clearance?

Aquadex FlexFlow System 2.0 received FDA 510(k) clearance on 2020-02-24, under 510(k) number K192756.

Who is the listed applicant for Aquadex FlexFlow System 2.0?

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

What is the FDA product code for Aquadex FlexFlow System 2.0?

The FDA product code for Aquadex FlexFlow System 2.0 is KDI.

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: KDI)

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

Официальный источник

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