FDA 510(k)

Evolve 电动吸奶器

K号: K190465 · 2019-10-18

决定日期2019-10-18

产品代码HGX

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决定实质等同

器械摘要

Evolve Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Hygeia II Medical Group, Inc.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K190465. 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 Evolve Breast Pump?

Evolve Breast Pump is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Hygeia II Medical Group, Inc.. The 510(k) number is K190465.

When did Evolve Breast Pump receive FDA 510(k) clearance?

Evolve Breast Pump received FDA 510(k) clearance on 2019-10-18, under 510(k) number K190465.

Who is the listed applicant for Evolve Breast Pump?

The FDA 510(k) record lists Hygeia II Medical Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evolve Breast Pump?

The FDA product code for Evolve Breast Pump is HGX.

列明Hygeia II Medical Group, Inc.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。

K233136Hygeia Express 电动吸奶器 K212955Fit Pro 乳腺泵 K200406Evolve 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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