FDA 510(k)

Aurelia外科口罩ASTM Level-3 (2130)

K 號：K242502 · 2024-11-12

申請人Supermax Healthcare Canada – Supermax Medical

決定日期2024-11-12

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

Aurelia Surgical Mask ASTM Level-3 (2130) is the device name listed in this FDA 510(k) record. The listed applicant is Supermax Healthcare Canada – Supermax Medical. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242502. 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 Aurelia Surgical Mask ASTM Level-3 (2130)?

Aurelia Surgical Mask ASTM Level-3 (2130) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Supermax Healthcare Canada – Supermax Medical. The 510(k) number is K242502.

When did Aurelia Surgical Mask ASTM Level-3 (2130) receive FDA 510(k) clearance?

Aurelia Surgical Mask ASTM Level-3 (2130) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242502.

Who is the listed applicant for Aurelia Surgical Mask ASTM Level-3 (2130)?

The FDA 510(k) record lists Supermax Healthcare Canada – Supermax Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurelia Surgical Mask ASTM Level-3 (2130)?

The FDA product code for Aurelia Surgical Mask ASTM Level-3 (2130) is FXX.

其他以 Supermax Healthcare Canada – Supermax Medical 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。

K231005Aurelia外科口罩ASTM Level 1; Aurelia外科口罩ASTM Level 2

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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