FDA 510(k)

VitreOx Anti-fog Solution

Номер K: K163257 · 2017-05-24

Дата решения2017-05-24

Код продуктаOCT

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

VitreOx Anti-fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Sio2 Nanotech, LLC. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K163257. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the VitreOx Anti-fog Solution?

VitreOx Anti-fog Solution is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Sio2 Nanotech, LLC. The 510(k) number is K163257.

When did VitreOx Anti-fog Solution receive FDA 510(k) clearance?

VitreOx Anti-fog Solution received FDA 510(k) clearance on 2017-05-24, under 510(k) number K163257.

Who is the listed applicant for VitreOx Anti-fog Solution?

The FDA 510(k) record lists Sio2 Nanotech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitreOx Anti-fog Solution?

The FDA product code for VitreOx Anti-fog Solution is OCT.

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: OCT)

K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc.K221293E-Brik Visualization AssistantJdi Surgical, Inc.K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd.K152948Medline Anti-Fog SolutionMedline Industries, 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.