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FDA 510(k)

Red Dot

K号: K191556 · 2020-02-28

决定日期2020-02-28
产品代码QFM
咨询委员会RA
决定实质等同

器械摘要

Red Dot is the device name listed in this FDA 510(k) record. The listed applicant is Behold.Ai Technologies Limited. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K191556. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Red Dot?

Red Dot is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Behold.Ai Technologies Limited. The 510(k) number is K191556.

When did Red Dot receive FDA 510(k) clearance?

Red Dot received FDA 510(k) clearance on 2020-02-28, under 510(k) number K191556.

Who is the listed applicant for Red Dot?

The FDA 510(k) record lists Behold.Ai Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Red Dot?

The FDA product code for Red Dot is QFM.

相关器械(代码:QFM)

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