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FDA 510(k)

trophon2

K 號:K250434 · 2025-08-05

申請人Nanosonics
決定日期2025-08-05
產品代碼OUJ
諮詢委員會RA
決定相當於

器材摘要

trophon2 is the device name listed in this FDA 510(k) record. The listed applicant is Nanosonics. It received FDA 510(k) clearance on 2025-08-05 under 510(k) number K250434. The device is classified under product code OUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the trophon2?

trophon2 is a medical device that received FDA 510(k) clearance on 2025-08-05. The listed applicant is Nanosonics. The 510(k) number is K250434.

When did trophon2 receive FDA 510(k) clearance?

trophon2 received FDA 510(k) clearance on 2025-08-05, under 510(k) number K250434.

Who is the listed applicant for trophon2?

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

What is the FDA product code for trophon2?

The FDA product code for trophon2 is OUJ.

相關臨床試驗

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相關器械(代碼:OUJ)

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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