FDA 510(k)

Hydrofera Blue READY - Border

Номер K: K190268 · 2019-11-06

Дата решения2019-11-06

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

Hydrofera Blue READY - Border is the device name listed in this FDA 510(k) record. The listed applicant is Hydrofera, LLC. It received FDA 510(k) clearance on 2019-11-06 under 510(k) number K190268. 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 Hydrofera Blue READY - Border?

Hydrofera Blue READY - Border is a medical device that received FDA 510(k) clearance on 2019-11-06. The listed applicant is Hydrofera, LLC. The 510(k) number is K190268.

When did Hydrofera Blue READY - Border receive FDA 510(k) clearance?

Hydrofera Blue READY - Border received FDA 510(k) clearance on 2019-11-06, under 510(k) number K190268.

Who is the listed applicant for Hydrofera Blue READY - Border?

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

What is the FDA product code for Hydrofera Blue READY - Border?

The FDA product code for Hydrofera Blue READY - Border 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.