FDA 510(k)

AMD 防霧解決方案

K 號：K181887 · 2019-01-22

決定日期2019-01-22

產品代碼OCT

諮詢委員會GU

決定相當於

器材摘要

AMD Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Design Co., Ltd.. It received FDA 510(k) clearance on 2019-01-22 under 510(k) number K181887. 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 AMD Anti-Fog Solution?

AMD Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Advanced Medical Design Co., Ltd.. The 510(k) number is K181887.

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

AMD Anti-Fog Solution received FDA 510(k) clearance on 2019-01-22, under 510(k) number K181887.

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

The FDA 510(k) record lists Advanced Medical Design Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Advanced Medical Design Co., Ltd. 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。

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官方來源

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