FDA 510(k)

trophon 電子無線超音波探頭固定器

K 號：K241536 · 2024-09-27

決定日期2024-09-27

產品代碼OUJ

諮詢委員會RA

決定相當於

器材摘要

trophon Wireless Ultrasound Probe Holder is the device name listed in this FDA 510(k) record. The listed applicant is Nanosonics Limited. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241536. 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 trophon Wireless Ultrasound Probe Holder?

trophon Wireless Ultrasound Probe Holder is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Nanosonics Limited. The 510(k) number is K241536.

When did trophon Wireless Ultrasound Probe Holder receive FDA 510(k) clearance?

trophon Wireless Ultrasound Probe Holder received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241536.

Who is the listed applicant for trophon Wireless Ultrasound Probe Holder?

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

What is the FDA product code for trophon Wireless Ultrasound Probe Holder?

The FDA product code for trophon Wireless Ultrasound Probe Holder is OUJ.

其他以 Nanosonics Limited 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。

K253267CORIS系統 K173865trophon2

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。

K250434trophon2Nanosonics K173865trophon2Nanosonics Limited

官方來源

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