FDA 510(k)

Falcon/Xpress (Falcon/Xpress)

K 號：K242662 · 2024-12-18

決定日期2024-12-18

產品代碼JOP

諮詢委員會履歷

決定相當於

器材摘要

Falcon/Xpress (Falcon/Xpress) is the device name listed in this FDA 510(k) record. The listed applicant is Viasonix , Ltd.. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K242662. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Falcon/Xpress (Falcon/Xpress)?

Falcon/Xpress (Falcon/Xpress) is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Viasonix , Ltd.. The 510(k) number is K242662.

When did Falcon/Xpress (Falcon/Xpress) receive FDA 510(k) clearance?

Falcon/Xpress (Falcon/Xpress) received FDA 510(k) clearance on 2024-12-18, under 510(k) number K242662.

Who is the listed applicant for Falcon/Xpress (Falcon/Xpress)?

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

What is the FDA product code for Falcon/Xpress (Falcon/Xpress)?

The FDA product code for Falcon/Xpress (Falcon/Xpress) is JOP.

其他以 Viasonix , 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：JOP）

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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