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FDA 510(k)

安全空氣煙霧排氣器 細巧型

K 號:K182224 · 2019-02-07

決定日期2019-02-07
產品代碼FYD
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

SafeAir Smoke Evacuator compact is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2019-02-07 under 510(k) number K182224. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SafeAir Smoke Evacuator compact?

SafeAir Smoke Evacuator compact is a medical device that received FDA 510(k) clearance on 2019-02-07. The listed applicant is Lina Medical Aps. The 510(k) number is K182224.

When did SafeAir Smoke Evacuator compact receive FDA 510(k) clearance?

SafeAir Smoke Evacuator compact received FDA 510(k) clearance on 2019-02-07, under 510(k) number K182224.

Who is the listed applicant for SafeAir Smoke Evacuator compact?

The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeAir Smoke Evacuator compact?

The FDA product code for SafeAir Smoke Evacuator compact is FYD.

相關臨床試驗

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其他以 Lina Medical Aps 為申請人之記錄

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相關器械(代碼:FYD)

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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