FDA 510(k)

紧凑型可穿戴泵

K号: K230469 · 2023-06-30

决定日期2023-06-30

产品代码HGX

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决定实质等同

器械摘要

Compact Wearable Pump is the device name listed in this FDA 510(k) record. The listed applicant is Lansinoh Laboratories. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230469. 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 Compact Wearable Pump?

Compact Wearable Pump is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Lansinoh Laboratories. The 510(k) number is K230469.

When did Compact Wearable Pump receive FDA 510(k) clearance?

Compact Wearable Pump received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230469.

Who is the listed applicant for Compact Wearable Pump?

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

What is the FDA product code for Compact Wearable Pump?

The FDA product code for Compact Wearable Pump is HGX.

列明Lansinoh Laboratories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。

K222726Smartpump 3.0 双电动吸奶器

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。