FDA 510(k)

Surgical Face Mask (L 175*95mm)

Номер K: K230617 · 2023-06-01

ЗаявительHenan Chaoya Medical Equipment Co., Ltd.

Дата решения2023-06-01

Код продуктаFXX

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Surgical Face Mask (L 175*95mm) is the device name listed in this FDA 510(k) record. The listed applicant is Henan Chaoya Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K230617. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Surgical Face Mask (L 175*95mm)?

Surgical Face Mask (L 175*95mm) is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Henan Chaoya Medical Equipment Co., Ltd.. The 510(k) number is K230617.

When did Surgical Face Mask (L 175*95mm) receive FDA 510(k) clearance?

Surgical Face Mask (L 175*95mm) received FDA 510(k) clearance on 2023-06-01, under 510(k) number K230617.

Who is the listed applicant for Surgical Face Mask (L 175*95mm)?

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

What is the FDA product code for Surgical Face Mask (L 175*95mm)?

The FDA product code for Surgical Face Mask (L 175*95mm) is FXX.

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: FXX)

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Официальный источник

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