FDA 510(k)

HFT750U

K 號：K242931 · 2025-05-15

決定日期2025-05-15

產品代碼MNT

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：MNT）

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官方來源

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