FDA 510(k)

One Mum 泵组

K号: K172067 · 2017-11-29

决定日期2017-11-29

产品代码HGX

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决定实质等同

器械摘要

One Mum Pumpset is the device name listed in this FDA 510(k) record. The listed applicant is Ardo Medical AG. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172067. 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 One Mum Pumpset?

One Mum Pumpset is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Ardo Medical AG. The 510(k) number is K172067.

When did One Mum Pumpset receive FDA 510(k) clearance?

One Mum Pumpset received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172067.

Who is the listed applicant for One Mum Pumpset?

The FDA 510(k) record lists Ardo Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Mum Pumpset?

The FDA product code for One Mum Pumpset is HGX.

列明Ardo Medical AG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。

K230590ARDO Bellis K212773ARDO Alyssa

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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