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FDA 510(k)

外科口罩(綁帶式/耳環式)

K 號:K240916 · 2024-10-18

決定日期2024-10-18
產品代碼FXX
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

Surgical Face Mask (Tie on/ Ear loops) is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Daoqi Plastic Co., Ltd.. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K240916. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgical Face Mask (Tie on/ Ear loops)?

Surgical Face Mask (Tie on/ Ear loops) is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Xiantao Daoqi Plastic Co., Ltd.. The 510(k) number is K240916.

When did Surgical Face Mask (Tie on/ Ear loops) receive FDA 510(k) clearance?

Surgical Face Mask (Tie on/ Ear loops) received FDA 510(k) clearance on 2024-10-18, under 510(k) number K240916.

Who is the listed applicant for Surgical Face Mask (Tie on/ Ear loops)?

The FDA 510(k) record lists Xiantao Daoqi Plastic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Mask (Tie on/ Ear loops)?

The FDA product code for Surgical Face Mask (Tie on/ Ear loops) is FXX.

相關臨床試驗

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相關器械(代碼:FXX)

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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