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FDA 510(k)

3層醫療口罩（XMM3L3C），3層醫療口罩帶綁帶（XMM3HT）

K 號：K210772 · 2021-09-22

申請人Vr Vertical, LLC Dba Xrgo
決定日期2021-09-22
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

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is the device name listed in this FDA 510(k) record. The listed applicant is Vr Vertical, LLC Dba Xrgo. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K210772. 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 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Vr Vertical, LLC Dba Xrgo. The 510(k) number is K210772.

When did 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) receive FDA 510(k) clearance?

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) received FDA 510(k) clearance on 2021-09-22, under 510(k) number K210772.

Who is the listed applicant for 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

The FDA 510(k) record lists Vr Vertical, LLC Dba Xrgo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

The FDA product code for 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is FXX.

相關臨床試驗

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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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。

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官方來源

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