FDA 510(k)

梅迪萊

K 號：K212000 · 2021-11-18

決定日期2021-11-18

產品代碼NUC

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

Medley is the device name listed in this FDA 510(k) record. The listed applicant is Good Clean Love, Inc.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K212000. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medley?

Medley is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Good Clean Love, Inc.. The 510(k) number is K212000.

When did Medley receive FDA 510(k) clearance?

Medley received FDA 510(k) clearance on 2021-11-18, under 510(k) number K212000.

Who is the listed applicant for Medley?

The FDA 510(k) record lists Good Clean Love, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medley?

The FDA product code for Medley is NUC.

其他以 Good Clean Love, Inc. 為申請人之記錄

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相關器械（代碼：NUC）

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。

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官方來源

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