FDA 510(k)

GOLFF 適用於醫療設備之無菌除霧溶液

K 號：K231822 · 2024-02-26

決定日期2024-02-26

產品代碼OCT

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：OCT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251068KnoxFog 防霧設備Uv One Hygienics, Inc.K221293E-Brik 医療設備規範文本 E-Brik 医學視覺輔助設備Jdi Surgical, Inc.K190864康尼克防霧解決方案Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler K181887AMD 防霧解決方案Advanced Medical Design Co., Ltd.K163257維特歐防霧溶液Sio2 Nanotech, LLC K152948美林防霧溶液Medline Industries, Inc.

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OCT）

官方來源