FDA 510(k)

AgeJet

K 號：K212472 · 2022-07-07

決定日期2022-07-07

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

AgeJet is the device name listed in this FDA 510(k) record. The listed applicant is Triworks Group Srl. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K212472. 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 AgeJet?

AgeJet is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Triworks Group Srl. The 510(k) number is K212472.

When did AgeJet receive FDA 510(k) clearance?

AgeJet received FDA 510(k) clearance on 2022-07-07, under 510(k) number K212472.

Who is the listed applicant for AgeJet?

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

What is the FDA product code for AgeJet?

The FDA product code for AgeJet is GEI.

其他以 Triworks Group Srl 為申請人之記錄

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K192621醫療用RF

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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