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FDA 510(k)

U 递送博联克ENFit肠内营养套装

K号: K190310 · 2019-05-31

申请人U Deliver Medical, LLC
决定日期2019-05-31
产品代码PIF
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

U Deliver Bolink ENFit Enteral Feeding Sets is the device name listed in this FDA 510(k) record. The listed applicant is U Deliver Medical, LLC. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190310. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the U Deliver Bolink ENFit Enteral Feeding Sets?

U Deliver Bolink ENFit Enteral Feeding Sets is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is U Deliver Medical, LLC. The 510(k) number is K190310.

When did U Deliver Bolink ENFit Enteral Feeding Sets receive FDA 510(k) clearance?

U Deliver Bolink ENFit Enteral Feeding Sets received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190310.

Who is the listed applicant for U Deliver Bolink ENFit Enteral Feeding Sets?

The FDA 510(k) record lists U Deliver Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U Deliver Bolink ENFit Enteral Feeding Sets?

The FDA product code for U Deliver Bolink ENFit Enteral Feeding Sets is PIF.

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U Deliver Medical, LLC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。

K170555U 递送博联克ENFit肠内营养套装

相关器械（代码：PIF）

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。

K260110丹诺美德胃造口按钮延长套件Danumed Medizintechnik GmbHK253715Edi 导管 ENFit 6Fr/48 cm (6893166)；Edi 导管 ENFit 6Fr/49cm (6893273)；Edi 导管 ENFit 6Fr/50cm (6893274)；Edi 导管 ENFit 8Fr/50cm (6893275)；Edi 导管 ENFit 8Fr/100cm (6893276)；Edi 导管 ENFit 8Fr/125cm (6893277)；Edi 导管 ENFit 12Fr/125cm (6893278)；Edi 导管 ENFit 16Fr/125cm (6893279)Maquet Critical Care ABK254170经皮内镜胃造瘘术（PEG）套件Degania Silicone , Ltd.K242917肠内引流系统，肠内药物吸管HMC Premedical S.p.A.K250481带ENFit®连接器的扩展输注套装SKY Medical, a.s.K240052一次性肠内营养喂养套装Beijing L&Z Medical Technology Development Co., Ltd.

官方来源

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