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FDA 510(k)

Philips Avent 单/双电动吸奶器高级

K号: K201381 · 2020-10-01

申请人Philips Consumer Lifestyle - Innovation Site Eindhoven
决定日期2020-10-01
产品代码HGX
咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Philips Avent Single/Double electric breast pump Advanced is the device name listed in this FDA 510(k) record. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. It received FDA 510(k) clearance on 2020-10-01 under 510(k) number K201381. 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 Philips Avent Single/Double electric breast pump Advanced?

Philips Avent Single/Double electric breast pump Advanced is a medical device that received FDA 510(k) clearance on 2020-10-01. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. The 510(k) number is K201381.

When did Philips Avent Single/Double electric breast pump Advanced receive FDA 510(k) clearance?

Philips Avent Single/Double electric breast pump Advanced received FDA 510(k) clearance on 2020-10-01, under 510(k) number K201381.

Who is the listed applicant for Philips Avent Single/Double electric breast pump Advanced?

The FDA 510(k) record lists Philips Consumer Lifestyle - Innovation Site Eindhoven as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Avent Single/Double electric breast pump Advanced?

The FDA product code for Philips Avent Single/Double electric breast pump Advanced is HGX.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Philips Consumer Lifestyle - Innovation Site Eindhoven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。

K203383Philips Avent 双电动吸奶器高级 SCF394/61, Philips Avent 双电动吸奶器高级 SCF394/62K161532Philips Avent Comfort 单/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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