FDA 510(k)

心電圖一次性導線

K 號：K170536 · 2017-04-24

決定日期2017-04-24

產品代碼DSA

諮詢委員會履歷

決定相當於

器材摘要

ECG Disposable Lead Wire is the device name listed in this FDA 510(k) record. The listed applicant is APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K170536. 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 ECG Disposable Lead Wire?

ECG Disposable Lead Wire is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is APK Technology Co., Ltd.. The 510(k) number is K170536.

When did ECG Disposable Lead Wire receive FDA 510(k) clearance?

ECG Disposable Lead Wire received FDA 510(k) clearance on 2017-04-24, under 510(k) number K170536.

Who is the listed applicant for ECG Disposable Lead Wire?

The FDA 510(k) record lists APK Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG Disposable Lead Wire?

The FDA product code for ECG Disposable Lead Wire is DSA.

其他以 APK Technology Co., Ltd. 為申請人之記錄

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K250425紫外光療法設備 K172981可重用SpO2感測器，一次性SpO2感測器

相關器械（代碼：DSA）

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