乔治·金·华法林血浆
K号: K161316 · 2017-02-23
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决定日期2017-02-23
产品代码GGN
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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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相关器械（代码：GGN）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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