FDA 510(k)

Konix Anti-Fog Solution

Номер K: K190864 · 2020-08-27

ЗаявительTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler

Дата решения2020-08-27

Код продуктаOCT

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Konix Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. It received FDA 510(k) clearance on 2020-08-27 under 510(k) number K190864. 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 Konix Anti-Fog Solution?

Konix Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2020-08-27. The listed applicant is Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. The 510(k) number is K190864.

When did Konix Anti-Fog Solution receive FDA 510(k) clearance?

Konix Anti-Fog Solution received FDA 510(k) clearance on 2020-08-27, under 510(k) number K190864.

Who is the listed applicant for Konix Anti-Fog Solution?

The FDA 510(k) record lists Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Konix Anti-Fog Solution?

The FDA product code for Konix 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.

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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.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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