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FDA 510(k)

Radify 分類

K 號:K231871 · 2024-01-17

決定日期2024-01-17
產品代碼QFM
諮詢委員會RA
決定相當於

器材摘要

Radify Triage is the device name listed in this FDA 510(k) record. The listed applicant is Envisionit Deepai, Ltd.. It received FDA 510(k) clearance on 2024-01-17 under 510(k) number K231871. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Radify Triage?

Radify Triage is a medical device that received FDA 510(k) clearance on 2024-01-17. The listed applicant is Envisionit Deepai, Ltd.. The 510(k) number is K231871.

When did Radify Triage receive FDA 510(k) clearance?

Radify Triage received FDA 510(k) clearance on 2024-01-17, under 510(k) number K231871.

Who is the listed applicant for Radify Triage?

The FDA 510(k) record lists Envisionit Deepai, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radify Triage?

The FDA product code for Radify Triage is QFM.

相關臨床試驗

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相關器械(代碼:QFM)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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