FDA 510(k)

卡迪那爾健康™ 三級外科口罩，配備防霧泡沫條

K 號：K192374 · 2019-12-02

決定日期2019-12-02

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

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K192374. 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 Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip?

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K192374.

When did Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip receive FDA 510(k) clearance?

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip received FDA 510(k) clearance on 2019-12-02, under 510(k) number K192374.

Who is the listed applicant for Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip?

The FDA product code for Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip is FXX.

其他以 Cardinal Health200, LLC 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。

K241780卡迪那爾健康公司硅膠檢查手套 K230838卡迪那爾健康™ 智能袍™ EDGE 通氣外科袍，配備 ASSIST™ 工具口袋 K223376Monoject Magellan 胰島素安全針筒 1mL, 31G x 6mm (8881893110)；Monoject Magellan 胰島素安全針筒 0.5mL, 31G x 6mm (8881893150)；Monoject Magellan 胰島素安全針筒 0.3mL, 31G x 6mm (8881893130)K230028肯德爾 SCD 智流控制器，卡迪納爾健康元素袖套，肯德爾 SCD 快速袖套，肯德爾 SCD 快速足環，肯德爾 SCD 逐漸壓縮舒適袖套，肯德爾 SCD 智流控制器管路組裝 K201592卡迪那爾健康Protexis PI藍色配Neu-Thera外科手套 K211390氰化藍無粉檢查手套

查看所有 14 項裝置 →

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。