FDA 510(k)

PUGGLE 肠内营养泵和喂养套装

K号: K200051 · 2020-09-25

决定日期2020-09-25

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

PUGGLE Enteral Feeding Pump and Feeding Set is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K200051. 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 PUGGLE Enteral Feeding Pump and Feeding Set?

PUGGLE Enteral Feeding Pump and Feeding Set is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Amsino International, Inc.. The 510(k) number is K200051.

When did PUGGLE Enteral Feeding Pump and Feeding Set receive FDA 510(k) clearance?

PUGGLE Enteral Feeding Pump and Feeding Set received FDA 510(k) clearance on 2020-09-25, under 510(k) number K200051.

Who is the listed applicant for PUGGLE Enteral Feeding Pump and Feeding Set?

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

What is the FDA product code for PUGGLE Enteral Feeding Pump and Feeding Set?

The FDA product code for PUGGLE Enteral Feeding Pump and Feeding Set is LZH.

列明Amsino International, Inc.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。

K252543AMSafe 注射器套装（BA-70075，BA-70071-D，BA-70070，BA-70071-P，BA-70072，BA-70072-F，BA-70071-DF，BA-70071-DF-120，FE01，FE04）K220230AMSure 肠内喂养泵 K220267AMSafe 无针连接器 K213522AMSafe 预充生理盐水冲洗注射器 K183473AMSafe(R) 预充生理盐水冲洗注射器 K181445AMSure 润滑间歇性导尿管

查看所有 11 个设备 →

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.K153074Kangaroo Connect肠内营养泵及Kangaroo Connect喂养套装，Kangaroo Connect PortalCovidien

官方来源

在 FDA 数据库中查看 →

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。