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FDA 510(k)

康尼克防霧解決方案

K 號:K190864 · 2020-08-27

決定日期2020-08-27
產品代碼OCT
諮詢委員會GU
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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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。

官方來源

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