FDA 510(k)

CER-S

K 號：K243312 · 2025-02-20

決定日期2025-02-20

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

CER-S is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocalm Srl. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K243312. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CER-S?

CER-S is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Cardiocalm Srl. The 510(k) number is K243312.

When did CER-S receive FDA 510(k) clearance?

CER-S received FDA 510(k) clearance on 2025-02-20, under 510(k) number K243312.

Who is the listed applicant for CER-S?

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

What is the FDA product code for CER-S?

The FDA product code for CER-S is DQK.

其他以 Cardiocalm Srl 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。

K213861CER-S

相關器械（代碼：DQK）

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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