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FDA 510(k)

胸腔視覺超音波設備

K 號:K241620 · 2025-02-27

申請人Gleamer Sas
決定日期2025-02-27
產品代碼MYN
諮詢委員會RA
決定相當於

器材摘要

ChestView US is the device name listed in this FDA 510(k) record. The listed applicant is Gleamer Sas. It received FDA 510(k) clearance on 2025-02-27 under 510(k) number K241620. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ChestView US?

ChestView US is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Gleamer Sas. The 510(k) number is K241620.

When did ChestView US receive FDA 510(k) clearance?

ChestView US received FDA 510(k) clearance on 2025-02-27, under 510(k) number K241620.

Who is the listed applicant for ChestView US?

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

What is the FDA product code for ChestView US?

The FDA product code for ChestView US is MYN.

相關臨床試驗

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其他以 Gleamer Sas 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。

相關器械(代碼:MYN)

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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