RGS; RGS Mini
K号: K222702 · 2023-06-02
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决定日期2023-06-02
产品代码FRA
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
RGS; RGS Mini is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Air, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K222702. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RGS; RGS Mini?
RGS; RGS Mini is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Genesis Air, Inc.. The 510(k) number is K222702.
When did RGS; RGS Mini receive FDA 510(k) clearance?
RGS; RGS Mini received FDA 510(k) clearance on 2023-06-02, under 510(k) number K222702.
Who is the listed applicant for RGS; RGS Mini?
The FDA 510(k) record lists Genesis Air, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RGS; RGS Mini?
The FDA product code for RGS; RGS Mini is FRA.
相关器械（代码：FRA）
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官方来源
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