FDA 510(k)

GOLFF Sterile Anti-Fog Solution

Номер K: K231822 · 2024-02-26

ЗаявительBatrik Medical Manufacturing, Inc.

Дата решения2024-02-26

Код продуктаOCT

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

GOLFF Sterile Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Batrik Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2024-02-26 under 510(k) number K231822. 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 GOLFF Sterile Anti-Fog Solution?

GOLFF Sterile Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Batrik Medical Manufacturing, Inc.. The 510(k) number is K231822.

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

GOLFF Sterile Anti-Fog Solution received FDA 510(k) clearance on 2024-02-26, under 510(k) number K231822.

Who is the listed applicant for GOLFF Sterile Anti-Fog Solution?

The FDA 510(k) record lists Batrik Medical Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for GOLFF Sterile 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.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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