FDA 510(k)

HaloGUARD Protective Disc with CHG

Номер K: K200641 · 2020-09-03

Дата решения2020-09-03

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

HaloGUARD Protective Disc with CHG is the device name listed in this FDA 510(k) record. The listed applicant is Attwill Medical Solutions. It received FDA 510(k) clearance on 2020-09-03 under 510(k) number K200641. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the HaloGUARD Protective Disc with CHG?

HaloGUARD Protective Disc with CHG is a medical device that received FDA 510(k) clearance on 2020-09-03. The listed applicant is Attwill Medical Solutions. The 510(k) number is K200641.

When did HaloGUARD Protective Disc with CHG receive FDA 510(k) clearance?

HaloGUARD Protective Disc with CHG received FDA 510(k) clearance on 2020-09-03, under 510(k) number K200641.

Who is the listed applicant for HaloGUARD Protective Disc with CHG?

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

What is the FDA product code for HaloGUARD Protective Disc with CHG?

The FDA product code for HaloGUARD Protective Disc with CHG is FRO. This falls under the Anesthesiology category.

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: FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Официальный источник

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