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FDA 510(k)

Temporis, Irix Plus

K 號：K231142 · 2024-04-25

申請人Dws S.R.L.
決定日期2024-04-25
產品代碼EBF
諮詢委員會DE
決定相當於

器材摘要

Temporis, Irix Plus is the device name listed in this FDA 510(k) record. The listed applicant is Dws S.R.L.. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K231142. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Temporis, Irix Plus?

Temporis, Irix Plus is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is Dws S.R.L.. The 510(k) number is K231142.

When did Temporis, Irix Plus receive FDA 510(k) clearance?

Temporis, Irix Plus received FDA 510(k) clearance on 2024-04-25, under 510(k) number K231142.

Who is the listed applicant for Temporis, Irix Plus?

The FDA 510(k) record lists Dws S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Temporis, Irix Plus?

The FDA product code for Temporis, Irix Plus is EBF.

相關臨床試驗

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相關器械（代碼：EBF）

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。

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官方來源

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