FDA 510(k)

TNI Clear-Guard™ 3 angled breathing filter (1545020)

Номер K: K223258 · 2023-06-15

Дата решения2023-06-15

Код продуктаCAH

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

TNI Clear-Guard™ 3 angled breathing filter (1545020) is the device name listed in this FDA 510(k) record. The listed applicant is Intersurgical , Ltd.. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K223258. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the TNI Clear-Guard™ 3 angled breathing filter (1545020)?

TNI Clear-Guard™ 3 angled breathing filter (1545020) is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Intersurgical , Ltd.. The 510(k) number is K223258.

When did TNI Clear-Guard™ 3 angled breathing filter (1545020) receive FDA 510(k) clearance?

TNI Clear-Guard™ 3 angled breathing filter (1545020) received FDA 510(k) clearance on 2023-06-15, under 510(k) number K223258.

Who is the listed applicant for TNI Clear-Guard™ 3 angled breathing filter (1545020)?

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

What is the FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020)?

The FDA product code for TNI Clear-Guard™ 3 angled breathing filter (1545020) is CAH.

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: CAH)

K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd.K251583Ambu® Virobac II® Фильтр выдыханияAmbu A/S K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp K222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K221472Filter and HME/FilterNingbo Huakun Medical Equipment Co., Ltd.

Официальный источник

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