FDA 510(k)

Ceevra Reveal 3+

K 號：K243933 · 2025-03-04

決定日期2025-03-04

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Ceevra Reveal 3+ is the device name listed in this FDA 510(k) record. The listed applicant is Ceevra, Inc.. It received FDA 510(k) clearance on 2025-03-04 under 510(k) number K243933. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ceevra Reveal 3+?

Ceevra Reveal 3+ is a medical device that received FDA 510(k) clearance on 2025-03-04. The listed applicant is Ceevra, Inc.. The 510(k) number is K243933.

When did Ceevra Reveal 3+ receive FDA 510(k) clearance?

Ceevra Reveal 3+ received FDA 510(k) clearance on 2025-03-04, under 510(k) number K243933.

Who is the listed applicant for Ceevra Reveal 3+?

FDA 510(k) 記錄將 Ceevra, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ceevra Reveal 3+?

The FDA product code for Ceevra Reveal 3+ is QIH.

其他以 Ceevra, Inc. 為申請人之記錄

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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相關器械（代碼：QIH）

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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