再製ArthroCare 耳鼻喉科電凝器
K 號：K172647 · 2018-02-21
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器材摘要
Reprocessed ArthroCare ENT Coblator is the device name listed in this FDA 510(k) record. The listed applicant is Renovo, Inc.. It received FDA 510(k) clearance on 2018-02-21 under 510(k) number K172647. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Reprocessed ArthroCare ENT Coblator?
Reprocessed ArthroCare ENT Coblator is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is Renovo, Inc.. The 510(k) number is K172647.
When did Reprocessed ArthroCare ENT Coblator receive FDA 510(k) clearance?
Reprocessed ArthroCare ENT Coblator received FDA 510(k) clearance on 2018-02-21, under 510(k) number K172647.
Who is the listed applicant for Reprocessed ArthroCare ENT Coblator?
The FDA 510(k) record lists Renovo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Reprocessed ArthroCare ENT Coblator?
The FDA product code for Reprocessed ArthroCare ENT Coblator is NUJ.
相關臨床試驗
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其他以 Renovo, Inc. 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：NUJ）
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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