FDA 510(k)

Breathing circuit bacterial/viral filter

Номер K: K222917 · 2024-02-15

ЗаявительShaoxing Haitech Medical Products Co., Ltd.

Дата решения2024-02-15

Код продуктаCAH

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

Breathing circuit bacterial/viral filter is the device name listed in this FDA 510(k) record. The listed applicant is Shaoxing Haitech Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2024-02-15 under 510(k) number K222917. 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 Breathing circuit bacterial/viral filter?

Breathing circuit bacterial/viral filter is a medical device that received FDA 510(k) clearance on 2024-02-15. The listed applicant is Shaoxing Haitech Medical Products Co., Ltd.. The 510(k) number is K222917.

When did Breathing circuit bacterial/viral filter receive FDA 510(k) clearance?

Breathing circuit bacterial/viral filter received FDA 510(k) clearance on 2024-02-15, under 510(k) number K222917.

Who is the listed applicant for Breathing circuit bacterial/viral filter?

The FDA 510(k) record lists Shaoxing Haitech Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breathing circuit bacterial/viral filter?

The FDA product code for Breathing circuit bacterial/viral filter 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 K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , Ltd.K221472Filter and HME/FilterNingbo Huakun Medical Equipment Co., Ltd.

Официальный источник

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