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FDA 510(k)

Master-Frank N95 離子氣體呼吸器

K 號：K172963 · 2018-04-04

申請人Master & Frank Enterprise Co., Ltd.
決定日期2018-04-04
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

Master-Frank N95 Particulate Respirator is the device name listed in this FDA 510(k) record. The listed applicant is Master & Frank Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K172963. 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 Master-Frank N95 Particulate Respirator?

Master-Frank N95 Particulate Respirator is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Master & Frank Enterprise Co., Ltd.. The 510(k) number is K172963.

When did Master-Frank N95 Particulate Respirator receive FDA 510(k) clearance?

Master-Frank N95 Particulate Respirator received FDA 510(k) clearance on 2018-04-04, under 510(k) number K172963.

Who is the listed applicant for Master-Frank N95 Particulate Respirator?

The FDA 510(k) record lists Master & Frank Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Master-Frank N95 Particulate Respirator?

The FDA product code for Master-Frank N95 Particulate Respirator 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

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。

K233022Halyard 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Owens & Minor (O&M) Halyard, Inc.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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