FDA 510(k)

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

K 號：K231005 · 2023-12-05

申請人Supermax Healthcare Canada-Supermax Medical

決定日期2023-12-05

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 1; Aurelia Surgical Mask ASTM Level 2 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 2023-12-05 under 510(k) number K231005. 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 1; Aurelia Surgical Mask ASTM Level 2?

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 is a medical device that received FDA 510(k) clearance on 2023-12-05. The listed applicant is Supermax Healthcare Canada-Supermax Medical. The 510(k) number is K231005.

When did Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 receive FDA 510(k) clearance?

Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 received FDA 510(k) clearance on 2023-12-05, under 510(k) number K231005.

Who is the listed applicant for Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2?

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 1; Aurelia Surgical Mask ASTM Level 2?

The FDA product code for Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 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。

K242502Aurelia外科口罩ASTM Level-3 (2130)

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。

K251967HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶；HALYARD* FLUIDSHIELD* 3 防霧術術口罩，配備 SO SOFT* 面料和 SO SOFT* 耳帶，並附帶 WrapAround Visor。O&M Halyard, Inc.K252534外科口罩（耳掛式）Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性外科口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性醫療口罩Makrite Industries, Inc.K243342KP防護口罩Kp Trading Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。