FDA 510(k)

電動乳泵（YM-8807、YM-8805、YM-8806、YM-8810）

K 號：K252342 · 2025-12-19

申請人Guangdong Youmeng Electrical Technology Co., Ltd.

決定日期2025-12-19

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 (YM-8807, YM-8805, YM-8806, YM-8810) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252342. 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 (YM-8807, YM-8805, YM-8806, YM-8810)?

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. The 510(k) number is K252342.

When did Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) receive FDA 510(k) clearance?

Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252342.

Who is the listed applicant for Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)?

FDA 510(k) 記錄將廣東有夢電氣技術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 (YM-8807, YM-8805, YM-8806, YM-8810)?

The FDA product code for Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) is HGX.

其他以 Guangdong Youmeng Electrical Technology 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。

K261298穿戴式電動乳泵 (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))K252754穿戴式電動乳泵 (YM-8803)K232466電動乳泵，型號：YM-8166

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。

K254203穿戴式乳泵（型號 S36）Shenzhen TPH Technology Co., Ltd.K261622飛利浦安進自然照護免手提電動乳罩泵（型號：SCF593/52，SCF593/62）；飛利浦安進自然照護加熱免手提電動乳罩泵（型號：SCF594/52，SCF594/62）Philips Consumer Lifestyle B.V.K262774穿戴式乳泵（型號：XN/MD-2249BS，ZFHF）Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre雙倍MaxCimilre Co., Ltd.K261298穿戴式電動乳泵 (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ 流動式穿戴乳房抽乳器（型號 S3）Shenzhen TPH Technology Co., Ltd.

官方來源

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