Helios+ UV-C System
K号: K242604 · 2025-05-27
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决定日期2025-05-27
产品代码QXJ
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。
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器械摘要
Helios+ UV-C System is the device name listed in this FDA 510(k) record. The listed applicant is Preventamed Technologies, Inc. Dba Surfacide Manufacturing. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K242604. The device is classified under product code QXJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Helios+ UV-C System?
Helios+ UV-C System is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is Preventamed Technologies, Inc. Dba Surfacide Manufacturing. The 510(k) number is K242604.
When did Helios+ UV-C System receive FDA 510(k) clearance?
Helios+ UV-C System received FDA 510(k) clearance on 2025-05-27, under 510(k) number K242604.
Who is the listed applicant for Helios+ UV-C System?
The FDA 510(k) record lists Preventamed Technologies, Inc. Dba Surfacide Manufacturing as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Helios+ UV-C System?
The FDA product code for Helios+ UV-C System is QXJ.
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