MA-40，MA-112
K号: K223835 · 2023-09-18
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决定日期2023-09-18
产品代码FRF
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
MA-40, MA-112 is the device name listed in this FDA 510(k) record. The listed applicant is Medify Air, LLC. It received FDA 510(k) clearance on 2023-09-18 under 510(k) number K223835. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MA-40, MA-112?
MA-40, MA-112 is a medical device that received FDA 510(k) clearance on 2023-09-18. The listed applicant is Medify Air, LLC. The 510(k) number is K223835.
When did MA-40, MA-112 receive FDA 510(k) clearance?
MA-40, MA-112 received FDA 510(k) clearance on 2023-09-18, under 510(k) number K223835.
Who is the listed applicant for MA-40, MA-112?
The FDA 510(k) record lists Medify Air, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MA-40, MA-112?
The FDA product code for MA-40, MA-112 is FRF.
相关器械（代码：FRF）
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官方来源
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