FDA 510(k)

AMSure® Одноразовый раствор生理ологического раствора для местного применения

Номер K: K201138 · 2021-04-14

Дата решения2021-04-14

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

AMSure® Single Use Saline Topical Solution is the device name listed in this FDA 510(k) record. The listed applicant is Amsino Medical, Inc.. It received FDA 510(k) clearance on 2021-04-14 under 510(k) number K201138. 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 AMSure® Single Use Saline Topical Solution?

AMSure® Single Use Saline Topical Solution is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Amsino Medical, Inc.. The 510(k) number is K201138.

When did AMSure® Single Use Saline Topical Solution receive FDA 510(k) clearance?

AMSure® Single Use Saline Topical Solution received FDA 510(k) clearance on 2021-04-14, under 510(k) number K201138.

Who is the listed applicant for AMSure® Single Use Saline Topical Solution?

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

What is the FDA product code for AMSure® Single Use Saline Topical Solution?

The FDA product code for AMSure® Single Use Saline Topical Solution 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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