FDA 510(k)

霍斯皮拉延長組，霍斯皮拉主要組

K 號：K161036 · 2017-01-06

決定日期2017-01-06

產品代碼FPA

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

Hospira Extension Set, Hospira Primary Set is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K161036. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hospira Extension Set, Hospira Primary Set?

Hospira Extension Set, Hospira Primary Set is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Hospira, Inc.. The 510(k) number is K161036.

When did Hospira Extension Set, Hospira Primary Set receive FDA 510(k) clearance?

Hospira Extension Set, Hospira Primary Set received FDA 510(k) clearance on 2017-01-06, under 510(k) number K161036.

Who is the listed applicant for Hospira Extension Set, Hospira Primary Set?

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 Hospira Extension Set, Hospira Primary Set?

The FDA product code for Hospira Extension Set, Hospira Primary Set is FPA.

其他以 Hospira, Inc. 為申請人之記錄

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相關器械（代碼：FPA）

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