FDA 510(k)

美林防霧溶液

K 號：K152948 · 2016-02-04

決定日期2016-02-04

產品代碼OCT

諮詢委員會GU

決定相當於

器材摘要

Medline Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K152948. 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 Medline Anti-Fog Solution?

Medline Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Medline Industries, Inc.. The 510(k) number is K152948.

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

Medline Anti-Fog Solution received FDA 510(k) clearance on 2016-02-04, under 510(k) number K152948.

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

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

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

The FDA product code for Medline Anti-Fog Solution is OCT.

其他以 Medline Industries, Inc. 為申請人之記錄

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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.K231822GOLFF 適用於醫療設備之無菌除霧溶液Batrik Medical Manufacturing, 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

官方來源

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