PIEZOTOME CUBE
K 號：K172137 · 2018-05-03
廣告
器材摘要
PIEZOTOME CUBE is the device name listed in this FDA 510(k) record. The listed applicant is Satelec - Acteon Group. It received FDA 510(k) clearance on 2018-05-03 under 510(k) number K172137. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PIEZOTOME CUBE?
PIEZOTOME CUBE is a medical device that received FDA 510(k) clearance on 2018-05-03. The listed applicant is Satelec - Acteon Group. The 510(k) number is K172137.
When did PIEZOTOME CUBE receive FDA 510(k) clearance?
PIEZOTOME CUBE received FDA 510(k) clearance on 2018-05-03, under 510(k) number K172137.
Who is the listed applicant for PIEZOTOME CUBE?
The FDA 510(k) record lists Satelec - Acteon Group as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PIEZOTOME CUBE?
The FDA product code for PIEZOTOME CUBE is DZI.
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。
其他以 Satelec - Acteon Group 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：DZI）
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。
K253655斜角螺絲刀醫療設備 (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776植入式醫療設備 Plus II 及 Piezomed Plus II 模組W&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340外科驅動系統（型號：ES70、ES90、E8）Guangdong Jinme Medical Technology Co., Ltd.K231087導航手術套件Implant Direct Sybron Manufacturing, LLC
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。
廣告