FDA 510(k)

rumble tuff 電動乳泵

K 號：K200712 · 2020-04-17

決定日期2020-04-17

產品代碼HGX

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

Rumble Tuff Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is A Cute Baby, Inc.. It received FDA 510(k) clearance on 2020-04-17 under 510(k) number K200712. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rumble Tuff Electric Breast Pump?

Rumble Tuff Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2020-04-17. The listed applicant is A Cute Baby, Inc.. The 510(k) number is K200712.

When did Rumble Tuff Electric Breast Pump receive FDA 510(k) clearance?

Rumble Tuff Electric Breast Pump received FDA 510(k) clearance on 2020-04-17, under 510(k) number K200712.

Who is the listed applicant for Rumble Tuff Electric Breast Pump?

The FDA 510(k) record lists A Cute Baby, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rumble Tuff Electric Breast Pump?

The FDA product code for Rumble Tuff Electric Breast Pump is HGX.

其他以 A Cute Baby, 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。

K252583迷你月亮電動乳罩泵（PA221）；月亮波電動乳罩泵（PA220）

相關器械（代碼：HGX）

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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