TalWire
K 號:K223791 · 2023-07-14
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器材摘要
TalWire is the device name listed in this FDA 510(k) record. The listed applicant is Embrace Medical , Ltd.. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K223791. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TalWire?
TalWire is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Embrace Medical , Ltd.. The 510(k) number is K223791.
When did TalWire receive FDA 510(k) clearance?
TalWire received FDA 510(k) clearance on 2023-07-14, under 510(k) number K223791.
Who is the listed applicant for TalWire?
The FDA 510(k) record lists Embrace Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TalWire?
The FDA product code for TalWire is DQX.
相關臨床試驗
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相關器械(代碼:DQX)
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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