HFT750U
K号: K242931 · 2025-05-15
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决定日期2025-05-15
产品代码MNT
咨询委员会AN
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决定实质等同
器械摘要
HFT750U is the device name listed in this FDA 510(k) record. The listed applicant is Mekics Co., Ltd.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K242931. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HFT750U?
HFT750U is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Mekics Co., Ltd.. The 510(k) number is K242931.
When did HFT750U receive FDA 510(k) clearance?
HFT750U received FDA 510(k) clearance on 2025-05-15, under 510(k) number K242931.
Who is the listed applicant for HFT750U?
The FDA 510(k) record lists Mekics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HFT750U?
The FDA product code for HFT750U is MNT.
相关器械(代码:MNT)
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官方来源
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