FDA 510(k)

Thermi 電波輔助設備

K 號：K161661 · 2016-08-12

申請人Thermi

決定日期2016-08-12

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

Thermi RF Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Thermi. It received FDA 510(k) clearance on 2016-08-12 under 510(k) number K161661. 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 Thermi RF Accessories?

Thermi RF Accessories is a medical device that received FDA 510(k) clearance on 2016-08-12. The listed applicant is Thermi. The 510(k) number is K161661.

When did Thermi RF Accessories receive FDA 510(k) clearance?

Thermi RF Accessories received FDA 510(k) clearance on 2016-08-12, under 510(k) number K161661.

Who is the listed applicant for Thermi RF Accessories?

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

What is the FDA product code for Thermi RF Accessories?

The FDA product code for Thermi RF Accessories is GEI.

其他以 Thermi 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。

K170116Thermi 注射式雷射電極

相關器械（代碼：GEI）

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。

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