FDA 510(k)

电动吸奶器 (YM-8807, YM-8805, YM-8806, YM-8810)

K号: K252342 · 2025-12-19

申请人Guangdong Youmeng Electrical Technology Co., Ltd.

决定日期2025-12-19

产品代码HGX

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

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.

常见问题

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)记录将广东优盟电气科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

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.

列明Guangdong Youmeng Electrical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261298可穿戴电动吸奶器（YM-8837，YM-8838，YM-8856(H03)，YM-8809(S42)）K252754可穿戴电动吸奶器（YM-8803）K232466电动吸奶器，型号：YM-8166

相关器械（代码：HGX）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254203可穿戴式乳腺泵（型号S36）Shenzhen TPH Technology Co., Ltd.K261622飞利浦新安怡自然护理免手提电动吸奶器（型号：SCF593/52，SCF593/62）；飞利浦新安怡自然护理加热免手提电动吸奶器（型号：SCF594/52，SCF594/62）Philips Consumer Lifestyle B.V.K262774可穿戴式乳腺泵（型号：XN/MD-2249BS，ZFHF）Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre 双重最大Cimilre Co., Ltd.K261298可穿戴电动吸奶器（YM-8837，YM-8838，YM-8856(H03)，YM-8809(S42)）Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ 流动式穿戴型乳房吸奶器（型号 S3）Shenzhen TPH Technology Co., Ltd.

官方来源

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