CT-STOR
K号: K201789 · 2021-09-20
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决定日期2021-09-20
产品代码NDS
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
CT-STOR is the device name listed in this FDA 510(k) record. The listed applicant is Energy Delivery Solutions. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K201789. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CT-STOR?
CT-STOR is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Energy Delivery Solutions. The 510(k) number is K201789.
When did CT-STOR receive FDA 510(k) clearance?
CT-STOR received FDA 510(k) clearance on 2021-09-20, under 510(k) number K201789.
Who is the listed applicant for CT-STOR?
The FDA 510(k) record lists Energy Delivery Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CT-STOR?
The FDA product code for CT-STOR is NDS.
相关器械（代码：NDS）
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官方来源
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