FDA 510(k)

LifeCare PCA Infusion System

K 號：K143612 · 2016-04-08

決定日期2016-04-08

產品代碼MEA

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

LifeCare PCA Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K143612. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LifeCare PCA Infusion System?

LifeCare PCA Infusion System is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Hospira, Inc.. The 510(k) number is K143612.

When did LifeCare PCA Infusion System receive FDA 510(k) clearance?

LifeCare PCA Infusion System received FDA 510(k) clearance on 2016-04-08, under 510(k) number K143612.

Who is the listed applicant for LifeCare PCA Infusion System?

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

What is the FDA product code for LifeCare PCA Infusion System?

The FDA product code for LifeCare PCA Infusion System is MEA.

其他以 Hospira, Inc. 為申請人之記錄

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相關器械（代碼：MEA）

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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