FDA 510(k)

神经和肌肉刺激器

K号: K193275 · 2020-04-11

决定日期2020-04-11

产品代码IPF

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决定实质等同

器械摘要

Nerve and Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xft Medical Limited. It received FDA 510(k) clearance on 2020-04-11 under 510(k) number K193275. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nerve and Muscle Stimulator?

Nerve and Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2020-04-11. The listed applicant is Shenzhen Xft Medical Limited. The 510(k) number is K193275.

When did Nerve and Muscle Stimulator receive FDA 510(k) clearance?

Nerve and Muscle Stimulator received FDA 510(k) clearance on 2020-04-11, under 510(k) number K193275.

Who is the listed applicant for Nerve and Muscle Stimulator?

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

What is the FDA product code for Nerve and Muscle Stimulator?

The FDA product code for Nerve and Muscle Stimulator is IPF.

列明Shenzhen Xft Medical Limited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。

K211094神经和肌肉刺激器 K193276神经和肌肉刺激器 K162718足下垂系统（型号XFT-2001D）

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。