FDA 510(k)

RT碳電極心電圖

K 號：K240087 · 2024-09-13

決定日期2024-09-13

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

RT Carbon ECG Leads is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240087. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RT Carbon ECG Leads?

RT Carbon ECG Leads is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K240087.

When did RT Carbon ECG Leads receive FDA 510(k) clearance?

RT Carbon ECG Leads received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240087.

Who is the listed applicant for RT Carbon ECG Leads?

The FDA 510(k) record lists Ivy Biomedical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RT Carbon ECG Leads?

The FDA product code for RT Carbon ECG Leads is DSA.

其他以 Ivy Biomedical Systems, Inc. 為申請人之記錄

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相關器械（代碼：DSA）

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