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FDA 510(k)

Halyard Fluidshield 3 N95 離子過濾式呼吸器及外科口罩，內層柔軟，橙色，規格：普通型及小號，Halyard Fluidshield 3 N95 離子過濾式呼吸器及外科口罩，配安全封口及柔軟內層，橙色，規格：普通型及小號，Halyard Fluidshield 2 N95 離子過濾式呼吸器及外科口罩，內層柔軟，白色，規格：普通型及小號

K 號：K233022 · 2024-01-12

申請人Owens & Minor (O&M) Halyard, Inc.
決定日期2024-01-12
產品代碼MSH
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

Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233022. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small?

Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. The 510(k) number is K233022.

When did Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small receive FDA 510(k) clearance?

Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233022.

Who is the listed applicant for Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small?

The FDA 510(k) record lists Owens & Minor (O&M) Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small?

The FDA product code for Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small is MSH.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Owens & Minor (O&M) Halyard, Inc. 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。

K243010Fluidshield * 3 防霧外科口罩配環繞防眩視鏡（28804）；Fluidshield * 3 外科口罩配SO SOFT* 開邊（48208）；Fluidshield * 3 防霧外科口罩配SO SOFT* 開邊（48207）；Fluidshield * 3 防霧外科口罩配SO SOFT* 開邊，附視鏡（48237）；Fluidshield* 3 防霧外科口罩配SO SOFT* 開邊，防眩環繞視鏡（48247）；Fluidshield * 3 防霧手術口罩配SO SOFT* 耳環（28797）；Fluidshield * 3 防霧程序口罩配SO SOFT* 耳環K232824FLUIDSHIELD* 1 防霧術術口罩，配 SO SOFT* 面料和 SO SOFT* 耳帶，白色（41802）；FLUIDSHIELD* 1 防霧術術口罩，配 SO SOFT* 面料和 SO SOFT* 耳帶，白色，全包覆護目鏡（41803）；FLUIDSHIELD* 1 外科口罩，配 SO SOFT* 面料，白色，（41805）K232777FLUIDSHIELD* 1 製程口罩，內層使用 SO SOFT*，耳帶也使用 SO SOFT*，薰衣草色（25868）；FLUIDSHIELD* 1 雾氣消除製程口罩，內層使用 SO SOFT*，耳帶也使用 SO SOFT*，薰衣草色，全包覆式護目鏡（41798）K232807Fluidshield* 1 遮濾口罩，內層採用SO SOFT* 面料，耳帶柔軟（25869）；Fluidshield* 1 外科口罩，內層採用SO SOFT* 面料（28802）K232812Fluidshield* 2 防霧術術口罩（62113）；Fluidshield* 2 防霧術術口罩配環繞護目鏡（62114）；Fluidshield* 2 手術程序口罩配SO SOFT* 耳環（62115）；Fluidshield* 2 手術程序口罩配SO SOFT* 耳環及環繞護目鏡（62116）K232806HALYARD* FLUIDSHIELD* 1 透氣性良好內層及柔軟耳帶手術口罩（25867）；HALYARD* 第一級手術口罩（48388）

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相關器械（代碼：MSH）

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。

K172963Master-Frank N95 離子氣體呼吸器Master & Frank Enterprise Co., Ltd.K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S3M HealthcareK160271N95 離子氣體呼吸器及外科口罩，型號 TN01-11 及 TN01-12San-M Package Co., Ltd.

官方來源

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