FDA 510(k)

病人電纜及導線，一次性心電圖導線

K 號：K182327 · 2019-01-30

決定日期2019-01-30

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

Patient Cables and Leadwires , Disposable ECG Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Orantech, Inc.. It received FDA 510(k) clearance on 2019-01-30 under 510(k) number K182327. 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 Patient Cables and Leadwires , Disposable ECG Leadwires?

Patient Cables and Leadwires , Disposable ECG Leadwires is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Orantech, Inc.. The 510(k) number is K182327.

When did Patient Cables and Leadwires , Disposable ECG Leadwires receive FDA 510(k) clearance?

Patient Cables and Leadwires , Disposable ECG Leadwires received FDA 510(k) clearance on 2019-01-30, under 510(k) number K182327.

Who is the listed applicant for Patient Cables and Leadwires , Disposable ECG Leadwires?

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

What is the FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires?

The FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires is DSA.

其他以 Orantech, Inc. 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。

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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。

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