定位器 R-Tx
K 號：K200827 · 2020-09-02
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器材摘要
LOCATOR R-Tx is the device name listed in this FDA 510(k) record. The listed applicant is Ivory Super Holdco, Incp.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K200827. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LOCATOR R-Tx?
LOCATOR R-Tx is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Ivory Super Holdco, Incp.. The 510(k) number is K200827.
When did LOCATOR R-Tx receive FDA 510(k) clearance?
LOCATOR R-Tx received FDA 510(k) clearance on 2020-09-02, under 510(k) number K200827.
Who is the listed applicant for LOCATOR R-Tx?
The FDA 510(k) record lists Ivory Super Holdco, Incp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LOCATOR R-Tx?
The FDA product code for LOCATOR R-Tx is NHA.
相關臨床試驗
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相關器械（代碼：NHA）
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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