FDA 510(k)

V30系統，V20系統，V10系統，V-FR手持式工具

K 號：K201064 · 2020-07-15

決定日期2020-07-15

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

V30 System, V20 System, V10 System, V-FR Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Viora , Ltd.. It received FDA 510(k) clearance on 2020-07-15 under 510(k) number K201064. 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 V30 System, V20 System, V10 System, V-FR Handpiece?

V30 System, V20 System, V10 System, V-FR Handpiece is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Viora , Ltd.. The 510(k) number is K201064.

When did V30 System, V20 System, V10 System, V-FR Handpiece receive FDA 510(k) clearance?

V30 System, V20 System, V10 System, V-FR Handpiece received FDA 510(k) clearance on 2020-07-15, under 510(k) number K201064.

Who is the listed applicant for V30 System, V20 System, V10 System, V-FR Handpiece?

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

What is the FDA product code for V30 System, V20 System, V10 System, V-FR Handpiece?

The FDA product code for V30 System, V20 System, V10 System, V-FR Handpiece is PBX.

其他以 Viora , Ltd. 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。

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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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