FDA 510(k)

Smart Photon Micro-current Device, Model: EP-300

K号: K162652 · 2017-10-25

申请人Li-Tek Electronic Technology Corporation

决定日期2017-10-25

产品代码NFO

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决定实质等同

器械摘要

Smart Photon Micro-current Device, Model: EP-300 is the device name listed in this FDA 510(k) record. The listed applicant is Li-Tek Electronic Technology Corporation. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K162652. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Smart Photon Micro-current Device, Model: EP-300?

Smart Photon Micro-current Device, Model: EP-300 is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Li-Tek Electronic Technology Corporation. The 510(k) number is K162652.

When did Smart Photon Micro-current Device, Model: EP-300 receive FDA 510(k) clearance?

Smart Photon Micro-current Device, Model: EP-300 received FDA 510(k) clearance on 2017-10-25, under 510(k) number K162652.

Who is the listed applicant for Smart Photon Micro-current Device, Model: EP-300?

The FDA 510(k) record lists Li-Tek Electronic Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Photon Micro-current Device, Model: EP-300?

The FDA product code for Smart Photon Micro-current Device, Model: EP-300 is NFO.

列明Li-Tek Electronic Technology Corporation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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