FDA 510(k)

Vibrant 系統

K 號：K232830 · 2023-12-08

決定日期2023-12-08

產品代碼QTN

諮詢委員會GU

決定相當於

器材摘要

Vibrant System is the device name listed in this FDA 510(k) record. The listed applicant is Vibrant, Ltd.. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K232830. The device is classified under product code QTN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vibrant System?

Vibrant System is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Vibrant, Ltd.. The 510(k) number is K232830.

When did Vibrant System receive FDA 510(k) clearance?

Vibrant System received FDA 510(k) clearance on 2023-12-08, under 510(k) number K232830.

Who is the listed applicant for Vibrant System?

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

What is the FDA product code for Vibrant System?

The FDA product code for Vibrant System is QTN.

其他以 Vibrant, Ltd. 為申請人之記錄

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K223031Vibrant 系統

相關器械（代碼：QTN）

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。

K223031Vibrant 系統Vibrant, Ltd.

官方來源

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