Stardust Med
K号: K200736 · 2020-06-26
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决定日期2020-06-26
产品代码GEX
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
Stardust Med is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. Group S.R.L.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200736. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the Stardust Med?
Stardust Med is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is I.T.S. Group S.R.L.. The 510(k) number is K200736.
When did Stardust Med receive FDA 510(k) clearance?
Stardust Med received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200736.
Who is the listed applicant for Stardust Med?
The FDA 510(k) record lists I.T.S. Group S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stardust Med?
The FDA product code for Stardust Med is GEX. This falls under the Gastroenterology category.
相关临床试验
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相关器械（代码：GEX）
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
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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