FDA 510(k)

肺淨清

K 號：K170784 · 2017-05-15

決定日期2017-05-15

產品代碼HIF

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

PNEUMOCLEAR is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2017-05-15 under 510(k) number K170784. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PNEUMOCLEAR?

PNEUMOCLEAR is a medical device that received FDA 510(k) clearance on 2017-05-15. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K170784.

When did PNEUMOCLEAR receive FDA 510(k) clearance?

PNEUMOCLEAR received FDA 510(k) clearance on 2017-05-15, under 510(k) number K170784.

Who is the listed applicant for PNEUMOCLEAR?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNEUMOCLEAR?

The FDA product code for PNEUMOCLEAR is HIF.

其他以 W.O.M. World of Medicine GmbH 為申請人之記錄

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相關器械（代碼：HIF）

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