FDA 510(k)

路達尼克斯基因頻率系統

K 號：K180945 · 2018-12-10

決定日期2018-12-10

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

LUTRONIC GENIUS Radiofrequency System is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K180945. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LUTRONIC GENIUS Radiofrequency System?

LUTRONIC GENIUS Radiofrequency System is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Lutronic Corporation. The 510(k) number is K180945.

When did LUTRONIC GENIUS Radiofrequency System receive FDA 510(k) clearance?

LUTRONIC GENIUS Radiofrequency System received FDA 510(k) clearance on 2018-12-10, under 510(k) number K180945.

Who is the listed applicant for LUTRONIC GENIUS Radiofrequency System?

The FDA 510(k) record lists Lutronic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUTRONIC GENIUS Radiofrequency System?

The FDA product code for LUTRONIC GENIUS Radiofrequency System is GEI.

其他以 Lutronic Corporation 為申請人之記錄

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