FDA 510(k)

維拉酷

K 號：K223287 · 2023-04-20

決定日期2023-04-20

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

Velacur is the device name listed in this FDA 510(k) record. The listed applicant is Sonic Incytes. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K223287. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Velacur?

Velacur is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Sonic Incytes. The 510(k) number is K223287.

When did Velacur receive FDA 510(k) clearance?

Velacur received FDA 510(k) clearance on 2023-04-20, under 510(k) number K223287.

Who is the listed applicant for Velacur?

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

What is the FDA product code for Velacur?

The FDA product code for Velacur is IYO.

其他以 Sonic Incytes 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。

K233977維拉酷 K232459維拉酷 K201597肝細胞，型號 1005

相關器械（代碼：IYO）

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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