FDA 510(k)

Venus RF 系統家族 - Venus Freedom

K 號：K211461 · 2021-10-14

決定日期2021-10-14

產品代碼PBX

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

Family of Venus RF Systems - Venus Freedom is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept USA, Inc.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K211461. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Family of Venus RF Systems - Venus Freedom?

Family of Venus RF Systems - Venus Freedom is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Venus Concept USA, Inc.. The 510(k) number is K211461.

When did Family of Venus RF Systems - Venus Freedom receive FDA 510(k) clearance?

Family of Venus RF Systems - Venus Freedom received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211461.

Who is the listed applicant for Family of Venus RF Systems - Venus Freedom?

The FDA 510(k) record lists Venus Concept USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Family of Venus RF Systems - Venus Freedom?

The FDA product code for Family of Venus RF Systems - Venus Freedom is PBX.

其他以 Venus Concept USA, Inc. 為申請人之記錄

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相關器械（代碼：PBX）

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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官方來源

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