FDA 510(k)

迷你月亮電動乳罩泵（PA221）；月亮波電動乳罩泵（PA220）

K 號：K252583 · 2026-03-12

決定日期2026-03-12

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

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) 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 2026-03-12 under 510(k) number K252583. 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 Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)?

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is A Cute Baby, Inc.. The 510(k) number is K252583.

When did Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) receive FDA 510(k) clearance?

Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252583.

Who is the listed applicant for Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)?

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 Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)?

The FDA product code for Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) 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。

K200712rumble tuff 電動乳泵

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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