FDA 510(k)

GGM Breathing Circuit Bacterial Filter

Номер K: K210352 · 2022-03-27

Дата решения2022-03-27

Код продуктаCAH

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

GGM Breathing Circuit Bacterial Filter is the device name listed in this FDA 510(k) record. The listed applicant is Great Group Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-03-27 under 510(k) number K210352. 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 GGM Breathing Circuit Bacterial Filter?

GGM Breathing Circuit Bacterial Filter is a medical device that received FDA 510(k) clearance on 2022-03-27. The listed applicant is Great Group Medical Co, Ltd.. The 510(k) number is K210352.

When did GGM Breathing Circuit Bacterial Filter receive FDA 510(k) clearance?

GGM Breathing Circuit Bacterial Filter received FDA 510(k) clearance on 2022-03-27, under 510(k) number K210352.

Who is the listed applicant for GGM Breathing Circuit Bacterial Filter?

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

What is the FDA product code for GGM Breathing Circuit Bacterial Filter?

The FDA product code for GGM Breathing Circuit Bacterial 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 K222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd.K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)Intersurgical , Ltd.

Официальный источник

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