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FDA 510(k)

喬治金·金氏抗凝血劑血液

K 號：K161316 · 2017-02-23

申請人George King Bio-Medical, Inc.
決定日期2017-02-23
產品代碼GGN
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

George King Coumadin Plasma is the device name listed in this FDA 510(k) record. The listed applicant is George King Bio-Medical, Inc.. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K161316. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the George King Coumadin Plasma?

George King Coumadin Plasma is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is George King Bio-Medical, Inc.. The 510(k) number is K161316.

When did George King Coumadin Plasma receive FDA 510(k) clearance?

George King Coumadin Plasma received FDA 510(k) clearance on 2017-02-23, under 510(k) number K161316.

Who is the listed applicant for George King Coumadin Plasma?

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

What is the FDA product code for George King Coumadin Plasma?

The FDA product code for George King Coumadin Plasma is GGN.

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相關器械（代碼：GGN）

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