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FDA 510(k)

Vesco Q™ 肠内营养泵；Vesco Q™ 500mL 注射袋喂食套装；Vesco Q™ 1000mL 注射袋喂食套装；Vesco Q™ 40mm 螺纹盖喂食套装；Vesco Q™ ENPlus 喂食套装

K号: K232205 · 2023-10-23

申请人Vesco Medical, LLC
决定日期2023-10-23
产品代码LZH
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set is the device name listed in this FDA 510(k) record. The listed applicant is Vesco Medical, LLC. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K232205. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set?

Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is Vesco Medical, LLC. The 510(k) number is K232205.

When did Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set receive FDA 510(k) clearance?

Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set received FDA 510(k) clearance on 2023-10-23, under 510(k) number K232205.

Who is the listed applicant for Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set?

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

What is the FDA product code for Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set?

The FDA product code for Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set is LZH.

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Vesco 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。

K192991维斯科医疗延长喂养套装K170162维斯科医疗鼻肠管K170218维斯科医疗NRFit注射器

相关器械（代码：LZH）

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。

K253558Luminoah FLOW™ 肠内营养系统LuminoahK221603Kangaroo OMNI™肠内营养泵（385400）；Kangaroo OMNI™喂养套装500ml（B5FD）；Kangaroo OMNI™ENtelliSet 500ml（E5FD）；Kangaroo OMNI™喂养套装1000ml（B10FD）；Kangaroo OMNI™ENtelliSet 1000ml（E10FD）；Kangaroo OMNI™ENPlus Spike Set（BSPFD）；Kangaroo OMNI™ENtelliSet ENPlus Spike（ESPFD）；Kangaroo OMNI™喂养套装500ml带冲洗袋（B5FF）；Kangaroo OMNI™ENtelliSet 500ml带冲洗袋（E5FF）；Kangaroo OMNI™喂养套装1000ml带冲洗袋（E10FF）；Kangaroo OMNI™Cardinal Health, LLCK220230AMSure 肠内喂养泵Amsino International, Inc.K200051PUGGLE 肠内营养泵和喂养套装Amsino International, Inc.K153074Kangaroo Connect肠内营养泵及Kangaroo Connect喂养套装，Kangaroo Connect PortalCovidien

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。

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