FDA 510(k)

Celerity 心電圖纜線配件組

K 號：K171931 · 2017-10-26

決定日期2017-10-26

產品代碼LJS

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Celerity ECG Cable Accessory Pack is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K171931. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Celerity ECG Cable Accessory Pack?

Celerity ECG Cable Accessory Pack is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Medcomp (Medical Components, Inc.). The 510(k) number is K171931.

When did Celerity ECG Cable Accessory Pack receive FDA 510(k) clearance?

Celerity ECG Cable Accessory Pack received FDA 510(k) clearance on 2017-10-26, under 510(k) number K171931.

Who is the listed applicant for Celerity ECG Cable Accessory Pack?

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

What is the FDA product code for Celerity ECG Cable Accessory Pack?

The FDA product code for Celerity ECG Cable Accessory Pack is LJS.

其他以 Medcomp (Medical Components, Inc.) 為申請人之記錄

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相關器械（代碼：LJS）

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