FDA 510(k)

S 配送線

K 號：K192770 · 2020-12-17

決定日期2020-12-17

產品代碼FMF

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

S dispensing line is the device name listed in this FDA 510(k) record. The listed applicant is Aea Srl. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K192770. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the S dispensing line?

S dispensing line is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Aea Srl. The 510(k) number is K192770.

When did S dispensing line receive FDA 510(k) clearance?

S dispensing line received FDA 510(k) clearance on 2020-12-17, under 510(k) number K192770.

Who is the listed applicant for S dispensing line?

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

What is the FDA product code for S dispensing line?

The FDA product code for S dispensing line is FMF.

其他以 Aea Srl 為申請人之記錄

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。

K203674B 配送線

相關器械（代碼：FMF）

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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