FDA 510(k)

柳叶可穿戴电动吸奶器 2.0

K号: K191577 · 2019-09-06

决定日期2019-09-06

产品代码HGX

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决定实质等同

器械摘要

Willow Wearable Breast Pump 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Exploramed Nc7, Inc.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191577. 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 Willow Wearable Breast Pump 2.0?

Willow Wearable Breast Pump 2.0 is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Exploramed Nc7, Inc.. The 510(k) number is K191577.

When did Willow Wearable Breast Pump 2.0 receive FDA 510(k) clearance?

Willow Wearable Breast Pump 2.0 received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191577.

Who is the listed applicant for Willow Wearable Breast Pump 2.0?

The FDA 510(k) record lists Exploramed Nc7, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Willow Wearable Breast Pump 2.0?

The FDA product code for Willow Wearable Breast Pump 2.0 is HGX.

列明Exploramed Nc7, 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。

K161266Athena 乳腺泵

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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