SyntrFuge System
K号: K203800 · 2021-07-02
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决定日期2021-07-02
产品代码MUU
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
SyntrFuge System is the device name listed in this FDA 510(k) record. The listed applicant is Syntr Health Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K203800. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SyntrFuge System?
SyntrFuge System is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Syntr Health Technologies, Inc.. The 510(k) number is K203800.
When did SyntrFuge System receive FDA 510(k) clearance?
SyntrFuge System received FDA 510(k) clearance on 2021-07-02, under 510(k) number K203800.
Who is the listed applicant for SyntrFuge System?
The FDA 510(k) record lists Syntr Health Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SyntrFuge System?
The FDA product code for SyntrFuge System is MUU.
相关临床试验
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相关器械（代码：MUU）
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。
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官方来源
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