FDA 510(k)

SMARTez 弹性输液泵

K号: K151650 · 2016-04-04

决定日期2016-04-04

产品代码MEB

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决定实质等同

器械摘要

SMARTez elastomeric infusion pump is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2016-04-04 under 510(k) number K151650. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SMARTez elastomeric infusion pump?

SMARTez elastomeric infusion pump is a medical device that received FDA 510(k) clearance on 2016-04-04. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K151650.

When did SMARTez elastomeric infusion pump receive FDA 510(k) clearance?

SMARTez elastomeric infusion pump received FDA 510(k) clearance on 2016-04-04, under 510(k) number K151650.

Who is the listed applicant for SMARTez elastomeric infusion pump?

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

What is the FDA product code for SMARTez elastomeric infusion pump?

The FDA product code for SMARTez elastomeric infusion pump is MEB.

列明Epic Medical Pte. , Ltd.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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官方来源

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