FDA 510(k)

HD+12, HD+15

K 號：K220526 · 2023-05-15

決定日期2023-05-15

產品代碼DRG

諮詢委員會履歷

決定相當於

器材摘要

HD+12, HD+15 is the device name listed in this FDA 510(k) record. The listed applicant is Cardioline S.P.A. It received FDA 510(k) clearance on 2023-05-15 under 510(k) number K220526. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HD+12, HD+15?

HD+12, HD+15 is a medical device that received FDA 510(k) clearance on 2023-05-15. The listed applicant is Cardioline S.P.A. The 510(k) number is K220526.

When did HD+12, HD+15 receive FDA 510(k) clearance?

HD+12, HD+15 received FDA 510(k) clearance on 2023-05-15, under 510(k) number K220526.

Who is the listed applicant for HD+12, HD+15?

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

What is the FDA product code for HD+12, HD+15?

The FDA product code for HD+12, HD+15 is DRG.

其他以 Cardioline S.P.A 為申請人之記錄

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官方來源

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