FDA 510(k)

电动吸奶器（FZ-P8）；电动吸奶器（YH-P8）；电动吸奶器（YH-P8X）

K号: K251977 · 2025-10-22

申请人Ningbo Youhe Electrical Appliance Technology Co., Ltd.

决定日期2025-10-22

产品代码HGX

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决定实质等同

器械摘要

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K251977. 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 (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Ningbo Youhe Electrical Appliance Technology Co., Ltd.. The 510(k) number is K251977.

When did electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) receive FDA 510(k) clearance?

electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251977.

Who is the listed applicant for electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

The FDA 510(k) record lists Ningbo Youhe Electrical Appliance Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)?

The FDA product code for electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) is HGX.

列明Ningbo Youhe Electrical Appliance 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。

K242725优哈电动吸奶器（The INs、The INs Gen2、The INs NEXT 和 P3）以及贝贝宝电动吸奶器（P1s）K203148尤哈电动吸奶器（型号：THE ONE，YH-8011，YH-8012，YH-8019，YY-5030）；贝贝宝电动吸奶器（型号：BB-5020）；宜雅多电动吸奶器（型号：YY-5030）K163136优哈电动吸奶器

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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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。