FDA 510(k)

CSF-4 (CSF-4)

K 號：K232445 · 2024-05-02

決定日期2024-05-02

產品代碼DPS

諮詢委員會履歷

決定相當於

器材摘要

CSF-4 (CSF-4) is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacsense. It received FDA 510(k) clearance on 2024-05-02 under 510(k) number K232445. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CSF-4 (CSF-4)?

CSF-4 (CSF-4) is a medical device that received FDA 510(k) clearance on 2024-05-02. The listed applicant is Cardiacsense. The 510(k) number is K232445.

When did CSF-4 (CSF-4) receive FDA 510(k) clearance?

CSF-4 (CSF-4) received FDA 510(k) clearance on 2024-05-02, under 510(k) number K232445.

Who is the listed applicant for CSF-4 (CSF-4)?

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

What is the FDA product code for CSF-4 (CSF-4)?

The FDA product code for CSF-4 (CSF-4) is DPS.

其他以 Cardiacsense 為申請人之記錄

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K221260CSF-3

相關器械（代碼：DPS）

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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