FDA 510(k)

智慧雙面穿戴式乳泵，電動雙邊乳泵

K 號：K230102 · 2023-09-21

申請人Huizhou Lvb Maternal and Infant Supplies Co., Ltd.

決定日期2023-09-21

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

Smart double sides wearable breast pump, Electric bilateral breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K230102. 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 Smart double sides wearable breast pump, Electric bilateral breast pump?

Smart double sides wearable breast pump, Electric bilateral breast pump is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. The 510(k) number is K230102.

When did Smart double sides wearable breast pump, Electric bilateral breast pump receive FDA 510(k) clearance?

Smart double sides wearable breast pump, Electric bilateral breast pump received FDA 510(k) clearance on 2023-09-21, under 510(k) number K230102.

Who is the listed applicant for Smart double sides wearable breast pump, Electric bilateral breast pump?

The FDA 510(k) record lists Huizhou Lvb Maternal and Infant Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart double sides wearable breast pump, Electric bilateral breast pump?

The FDA product code for Smart double sides wearable breast pump, Electric bilateral breast pump is HGX.

其他以 Huizhou Lvb Maternal and Infant Supplies Co., Ltd. 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。

K252192穿戴式乳泵（P9、P10、P16、P20、P21、P22、P23、P25）K241004穿戴式乳泵（ABP-1508PRO、ABP-1506、ABP-1306、ABP-1306 PRO、M1、M3、M8、M5、M6、K1、K2、K3、K5、ABP-1306PLUS、ABP-1308、M2）

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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