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FDA 510(k)

Evenflo Premium双电动吸奶器（型号4018）

K号: K230481 · 2023-11-03

申请人Evenflo Feeding, Inc.
决定日期2023-11-03
产品代码HGX
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决定实质等同

器械摘要

Evenflo Premium Double Electric Breast Pump (Model 4018) is the device name listed in this FDA 510(k) record. The listed applicant is Evenflo Feeding, Inc.. It received FDA 510(k) clearance on 2023-11-03 under 510(k) number K230481. 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 Evenflo Premium Double Electric Breast Pump (Model 4018)?

Evenflo Premium Double Electric Breast Pump (Model 4018) is a medical device that received FDA 510(k) clearance on 2023-11-03. The listed applicant is Evenflo Feeding, Inc.. The 510(k) number is K230481.

When did Evenflo Premium Double Electric Breast Pump (Model 4018) receive FDA 510(k) clearance?

Evenflo Premium Double Electric Breast Pump (Model 4018) received FDA 510(k) clearance on 2023-11-03, under 510(k) number K230481.

Who is the listed applicant for Evenflo Premium Double Electric Breast Pump (Model 4018)?

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

What is the FDA product code for Evenflo Premium Double Electric Breast Pump (Model 4018)?

The FDA product code for Evenflo Premium Double Electric Breast Pump (Model 4018) 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

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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