FDA 510(k)

IRRAflow Active Fluid Exchange System (AFES)

Номер K: K222471 · 2022-12-08

ЗаявительIrras USA

Дата решения2022-12-08

Код продуктаJXG

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

IRRAflow Active Fluid Exchange System (AFES) is the device name listed in this FDA 510(k) record. The listed applicant is Irras USA. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K222471. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the IRRAflow Active Fluid Exchange System (AFES)?

IRRAflow Active Fluid Exchange System (AFES) is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Irras USA. The 510(k) number is K222471.

When did IRRAflow Active Fluid Exchange System (AFES) receive FDA 510(k) clearance?

IRRAflow Active Fluid Exchange System (AFES) received FDA 510(k) clearance on 2022-12-08, under 510(k) number K222471.

Who is the listed applicant for IRRAflow Active Fluid Exchange System (AFES)?

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

What is the FDA product code for IRRAflow Active Fluid Exchange System (AFES)?

The FDA product code for IRRAflow Active Fluid Exchange System (AFES) is JXG.

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: JXG)

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Официальный источник

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