FDA 510(k)

Artiglass NRFitTM Tip L.O.R. Glass Syringes

Номер K: K213800 · 2022-05-19

Дата решения2022-05-19

Код продуктаQEH

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Artiglass NRFitTM Tip L.O.R. Glass Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Artiglass Srl. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K213800. The device is classified under product code QEH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Artiglass NRFitTM Tip L.O.R. Glass Syringes?

Artiglass NRFitTM Tip L.O.R. Glass Syringes is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Artiglass Srl. The 510(k) number is K213800.

When did Artiglass NRFitTM Tip L.O.R. Glass Syringes receive FDA 510(k) clearance?

Artiglass NRFitTM Tip L.O.R. Glass Syringes received FDA 510(k) clearance on 2022-05-19, under 510(k) number K213800.

Who is the listed applicant for Artiglass NRFitTM Tip L.O.R. Glass Syringes?

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

What is the FDA product code for Artiglass NRFitTM Tip L.O.R. Glass Syringes?

The FDA product code for Artiglass NRFitTM Tip L.O.R. Glass Syringes is QEH.

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: QEH)

K241385Omnifix Syringe NRFitB.Braun Medical, Inc.K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc.K192538BD Syringe NRFit Lok and BD Syringe NRFit SlipBecton, Dickinson and Company K181374NRFit SyringeJiangsu Caina Medical Co.,Ltd

Официальный источник

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