FDA 510(k)

Q2多端口靜脈注射輸液組合及延伸組合，Checkmate多端口靜脈注射輸液組合，Q2延伸組合

K 號：K162304 · 2016-12-06

決定日期2016-12-06

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

Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 2016-12-06 under 510(k) number K162304. 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 Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets?

Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets is a medical device that received FDA 510(k) clearance on 2016-12-06. The listed applicant is Quest Medical, Inc.. The 510(k) number is K162304.

When did Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets receive FDA 510(k) clearance?

Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets received FDA 510(k) clearance on 2016-12-06, under 510(k) number K162304.

Who is the listed applicant for Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets?

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

What is the FDA product code for Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets?

The FDA product code for Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets is FPA.