UV智能D60
K号: K251354 · 2026-01-29
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决定日期2026-01-29
产品代码SCS
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
UV Smart D60 is the device name listed in this FDA 510(k) record. The listed applicant is UV Smart Technologies B.V.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K251354. The device is classified under product code SCS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UV Smart D60?
UV Smart D60 is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is UV Smart Technologies B.V.. The 510(k) number is K251354.
When did UV Smart D60 receive FDA 510(k) clearance?
UV Smart D60 received FDA 510(k) clearance on 2026-01-29, under 510(k) number K251354.
Who is the listed applicant for UV Smart D60?
The FDA 510(k) record lists UV Smart Technologies B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UV Smart D60?
The FDA product code for UV Smart D60 is SCS.
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官方来源
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