SmartHDM-510系统
K号: K201765 · 2020-09-02
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决定日期2020-09-02
产品代码FIZ
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
SmartHDM-510 System is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Laboratories, Inc.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K201765. The device is classified under product code FIZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SmartHDM-510 System?
SmartHDM-510 System is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Mesa Laboratories, Inc.. The 510(k) number is K201765.
When did SmartHDM-510 System receive FDA 510(k) clearance?
SmartHDM-510 System received FDA 510(k) clearance on 2020-09-02, under 510(k) number K201765.
Who is the listed applicant for SmartHDM-510 System?
The FDA 510(k) record lists Mesa Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartHDM-510 System?
The FDA product code for SmartHDM-510 System is FIZ.
相关临床试验
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列明Mesa Laboratories, Inc.为申报人的其他记录
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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