FDA 510(k)

C50

K 號：K223470 · 2023-12-14

申請人Sopro

決定日期2023-12-14

產品代碼NBL

諮詢委員會DE

決定相當於

器材摘要

C50 is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K223470. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the C50?

C50 is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Sopro. The 510(k) number is K223470.

When did C50 receive FDA 510(k) clearance?

C50 received FDA 510(k) clearance on 2023-12-14, under 510(k) number K223470.

Who is the listed applicant for C50?

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

What is the FDA product code for C50?

The FDA product code for C50 is NBL.

相關器械（代碼：NBL）

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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