FDA 510(k)

ELECTROCYN soma

Номер K: K220286 · 2022-12-21

Дата решения2022-12-21

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

ELECTROCYN soma is the device name listed in this FDA 510(k) record. The listed applicant is V3Bio Sdn. Bhd. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K220286. 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 ELECTROCYN soma?

ELECTROCYN soma is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is V3Bio Sdn. Bhd. The 510(k) number is K220286.

When did ELECTROCYN soma receive FDA 510(k) clearance?

ELECTROCYN soma received FDA 510(k) clearance on 2022-12-21, under 510(k) number K220286.

Who is the listed applicant for ELECTROCYN soma?

The FDA 510(k) record lists V3Bio Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROCYN soma?

The FDA product code for ELECTROCYN soma 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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