FDA 510(k)

Talymed Suspension

Номер K: K160695 · 2016-12-06

ЗаявительMarine Polymer Technologies, Inc.

Дата решения2016-12-06

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

Talymed Suspension is the device name listed in this FDA 510(k) record. The listed applicant is Marine Polymer Technologies, Inc.. It received FDA 510(k) clearance on 2016-12-06 under 510(k) number K160695. 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 Talymed Suspension?

Talymed Suspension is a medical device that received FDA 510(k) clearance on 2016-12-06. The listed applicant is Marine Polymer Technologies, Inc.. The 510(k) number is K160695.

When did Talymed Suspension receive FDA 510(k) clearance?

Talymed Suspension received FDA 510(k) clearance on 2016-12-06, under 510(k) number K160695.

Who is the listed applicant for Talymed Suspension?

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

What is the FDA product code for Talymed Suspension?

The FDA product code for Talymed Suspension 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.