单一端口
K号: K232062 · 2024-01-16
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决定日期2024-01-16
产品代码OTJ
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
Uni-port is the device name listed in this FDA 510(k) record. The listed applicant is Dalim Medical Corp.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K232062. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Uni-port?
Uni-port is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Dalim Medical Corp.. The 510(k) number is K232062.
When did Uni-port receive FDA 510(k) clearance?
Uni-port received FDA 510(k) clearance on 2024-01-16, under 510(k) number K232062.
Who is the listed applicant for Uni-port?
The FDA 510(k) record lists Dalim Medical Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Uni-port?
The FDA product code for Uni-port is OTJ.
相关器械（代码：OTJ）
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官方来源
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