TuxDeluxe（尺寸1 6100B，尺寸2 6101B）
K 號：K232552 · 2023-10-20
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器材摘要
TuxDeluxe (Size 1 6100B, Size 2 6101B) is the device name listed in this FDA 510(k) record. The listed applicant is Tuxedo Imaging, LLC. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K232552. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TuxDeluxe (Size 1 6100B, Size 2 6101B)?
TuxDeluxe (Size 1 6100B, Size 2 6101B) is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Tuxedo Imaging, LLC. The 510(k) number is K232552.
When did TuxDeluxe (Size 1 6100B, Size 2 6101B) receive FDA 510(k) clearance?
TuxDeluxe (Size 1 6100B, Size 2 6101B) received FDA 510(k) clearance on 2023-10-20, under 510(k) number K232552.
Who is the listed applicant for TuxDeluxe (Size 1 6100B, Size 2 6101B)?
The FDA 510(k) record lists Tuxedo Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TuxDeluxe (Size 1 6100B, Size 2 6101B)?
The FDA product code for TuxDeluxe (Size 1 6100B, Size 2 6101B) is MUH.
相關臨床試驗
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：MUH）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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