FDA 510(k)

Kangaroo Connect肠内营养泵及Kangaroo Connect喂养套装，Kangaroo Connect Portal

K号: K153074 · 2016-07-06

决定日期2016-07-06

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

Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K153074. 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 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal?

Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Covidien. The 510(k) number is K153074.

When did Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal receive FDA 510(k) clearance?

Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal received FDA 510(k) clearance on 2016-07-06, under 510(k) number K153074.

Who is the listed applicant for Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal?

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

What is the FDA product code for Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal?

The FDA product code for Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal is LZH.

列明Covidien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。

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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Luminoah K232205Vesco 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Vesco Medical, LLC K221603Kangaroo 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, LLC K220230AMSure 肠内喂养泵Amsino International, Inc.K200051PUGGLE 肠内营养泵和喂养套装Amsino International, Inc.

官方来源

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