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FDA 510(k)

智慧光子微電流設備,型號:EP-300

K 號:K162652 · 2017-10-25

決定日期2017-10-25
產品代碼NFO
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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其他以 Li-Tek Electronic Technology Corporation 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

相關器械(代碼:NFO)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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