FDA 510(k)

电动吸奶器 (型号 KP033_01), 电动双吸奶器 (型号 KP053_01)

K号: K193449 · 2020-09-11

申请人Guangdong Horigen Mother & Baby Products Co., Ltd.

决定日期2020-09-11

产品代码HGX

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决定实质等同

器械摘要

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.

常见问题

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)记录将广东好基因母婴用品有限公司列为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Guangdong Horigen Mother & Baby Products 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。

K262774可穿戴式乳腺泵（型号：XN/MD-2249BS，ZFHF）K212564电动吸奶器 K201152电动吸奶器 K201974一次性医用口罩 K182413电动吸奶器 K162747Proture 双电乳腺泵

查看所有 7 个设备 →

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

在 FDA 数据库中查看 →

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。