FDA 510(k)

失禁治疗设备，型号LT2061

K号: K171430 · 2018-03-15

申请人Shenzhen Dongdixin Technology Co., Ltd.

决定日期2018-03-15

产品代码KPI

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决定实质等同

器械摘要

Incontinence Treatment Device, Model LT2061 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K171430. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Incontinence Treatment Device, Model LT2061?

Incontinence Treatment Device, Model LT2061 is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K171430.

When did Incontinence Treatment Device, Model LT2061 receive FDA 510(k) clearance?

Incontinence Treatment Device, Model LT2061 received FDA 510(k) clearance on 2018-03-15, under 510(k) number K171430.

Who is the listed applicant for Incontinence Treatment Device, Model LT2061?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Incontinence Treatment Device, Model LT2061?

The FDA product code for Incontinence Treatment Device, Model LT2061 is KPI.

列明Shenzhen Dongdixin Technology Co., 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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相关器械（代码：KPI）

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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