FDA 510(k)

KnoxFog Anti-fogging Device

Номер K: K251068 · 2025-08-27

Дата решения2025-08-27

Код продуктаOCT

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

KnoxFog Anti-fogging Device is the device name listed in this FDA 510(k) record. The listed applicant is Uv One Hygienics, Inc.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K251068. 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 KnoxFog Anti-fogging Device?

KnoxFog Anti-fogging Device is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Uv One Hygienics, Inc.. The 510(k) number is K251068.

When did KnoxFog Anti-fogging Device receive FDA 510(k) clearance?

KnoxFog Anti-fogging Device received FDA 510(k) clearance on 2025-08-27, under 510(k) number K251068.

Who is the listed applicant for KnoxFog Anti-fogging Device?

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

What is the FDA product code for KnoxFog Anti-fogging Device?

The FDA product code for KnoxFog Anti-fogging Device 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.

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Связанные устройства (Код: OCT)

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.K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLC K152948Medline Anti-Fog SolutionMedline Industries, Inc.

Официальный источник

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