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FDA 510(k)

Medwell Technology Ltd 靜脈針,各種尺寸

K 號:K212764 · 2022-11-04

決定日期2022-11-04
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

Medwell Technology Ltd Syringes, various sizes is the device name listed in this FDA 510(k) record. The listed applicant is Medwell Technology, Ltd.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K212764. 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 Medwell Technology Ltd Syringes, various sizes?

Medwell Technology Ltd Syringes, various sizes is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Medwell Technology, Ltd.. The 510(k) number is K212764.

When did Medwell Technology Ltd Syringes, various sizes receive FDA 510(k) clearance?

Medwell Technology Ltd Syringes, various sizes received FDA 510(k) clearance on 2022-11-04, under 510(k) number K212764.

Who is the listed applicant for Medwell Technology Ltd Syringes, various sizes?

The FDA 510(k) record lists Medwell Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medwell Technology Ltd Syringes, various sizes?

The FDA product code for Medwell Technology Ltd Syringes, various sizes is FMF.

相關臨床試驗

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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。

官方來源

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