FDA 510(k)

電動乳泵（型號 KP033_01）、電動雙乳泵（型號 KP053_01）

K 號：K193449 · 2020-09-11

申請人Guangdong Horigen Mother & Baby Products Co., Ltd.

決定日期2020-09-11

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

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K193449. 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 Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K193449.

When did Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) receive FDA 510(k) clearance?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) received FDA 510(k) clearance on 2020-09-11, under 510(k) number K193449.

Who is the listed applicant for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

FDA 510(k) 記錄將廣東省好榮根母嬰產品有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

The FDA product code for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is HGX.

其他以 Guangdong Horigen Mother & Baby Products 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。

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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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