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FDA 510(k)

ThermiX 體溫控制雷射系統，配件 - 雷射電極

K 號：K173582 · 2018-01-17

申請人Thermigen, L.L.C
決定日期2018-01-17
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

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Thermigen, L.L.C. It received FDA 510(k) clearance on 2018-01-17 under 510(k) number K173582. 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 ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes?

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Thermigen, L.L.C. The 510(k) number is K173582.

When did ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes receive FDA 510(k) clearance?

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes received FDA 510(k) clearance on 2018-01-17, under 510(k) number K173582.

Who is the listed applicant for ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes?

The FDA 510(k) record lists Thermigen, L.L.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes?

The FDA product code for ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes is GEI.

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