TORPEDO 嵌入式系統®
K 號：K230817 · 2024-01-19
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器材摘要
TORPEDO Implant System® is the device name listed in this FDA 510(k) record. The listed applicant is Deltacor GmbH. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K230817. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TORPEDO Implant System®?
TORPEDO Implant System® is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Deltacor GmbH. The 510(k) number is K230817.
When did TORPEDO Implant System® receive FDA 510(k) clearance?
TORPEDO Implant System® received FDA 510(k) clearance on 2024-01-19, under 510(k) number K230817.
Who is the listed applicant for TORPEDO Implant System®?
The FDA 510(k) record lists Deltacor GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TORPEDO Implant System®?
The FDA product code for TORPEDO Implant System® is OUR.
相關臨床試驗
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相關器械（代碼：OUR）
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
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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