FDA 510(k)

醫用連接式一次性心電圖電纜及導線

K 號：K220447 · 2022-06-28

申請人Shenzhen Med-Link Electronics Tech Co., Ltd.

決定日期2022-06-28

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

Med-link Disposable ECG Cable and Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-06-28 under 510(k) number K220447. 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 Med-link Disposable ECG Cable and Leadwires?

Med-link Disposable ECG Cable and Leadwires is a medical device that received FDA 510(k) clearance on 2022-06-28. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K220447.

When did Med-link Disposable ECG Cable and Leadwires receive FDA 510(k) clearance?

Med-link Disposable ECG Cable and Leadwires received FDA 510(k) clearance on 2022-06-28, under 510(k) number K220447.

Who is the listed applicant for Med-link Disposable ECG Cable and Leadwires?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-link Disposable ECG Cable and Leadwires?

The FDA product code for Med-link Disposable ECG Cable and Leadwires is DSA.

其他以 Shenzhen Med-Link Electronics Tech Co., Ltd. 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。

K251160無菌溫度探針（型號：W0001ES、W0028ES、W0101FS-A、W0101FS-P、W0099LS、W0099FS、W0099PS）K220448一次性非侵入式電腦電流圖感測器 K212752醫用連接式脈搏血氧計 K210441失禁檢測器 K202743Med-Link Temp-pulse 氧氣濃度計 K193338Med-link 可重用溫度探針，Med-link 一次性溫度探針

查看所有 11 項裝置 →

相關器械（代碼：DSA）

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。

官方來源

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