FDA 510(k)

NAVI

K 號：K170360 · 2017-05-02

決定日期2017-05-02

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

NAVIO is the device name listed in this FDA 510(k) record. The listed applicant is Blue Belt Technologies, Inc.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K170360. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NAVIO?

NAVIO is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Blue Belt Technologies, Inc.. The 510(k) number is K170360.

When did NAVIO receive FDA 510(k) clearance?

NAVIO received FDA 510(k) clearance on 2017-05-02, under 510(k) number K170360.

Who is the listed applicant for NAVIO?

The FDA 510(k) record lists Blue Belt Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIO?

The FDA product code for NAVIO is OLO.

其他以 Blue Belt Technologies, 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。

K260601REAL INTELLIGENCE™ CORI™K252841REAL INTELLIGENCE™ CORI™ XT (CORI XT)K250921CORIOGRAPH 預術規劃與建模服務 K242272CORIOGRAPH 預術規劃與建模服務 K240139真智慧™ CORI™K231963REAL INTELLIGENCE™ CORI™

查看所有 17 項裝置 →

相關器械（代碼：OLO）

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。

K262506Remex脊椎手術導航 - 適用儀器Remex Medical Corp.K261410Navbit MARQ (PRD-001-SUP（仰臥登錄套件），PRD-001-LAT（側臥登錄套件）)Suite 201, National Innovation Centre K261205脊椎藝術導航儀器系統Spineart SA K261024TMINI 微型機器人系統THINK Surgical, Inc.K262121離子-L導航儀器SurGenTec, LLC K261113Op.n™脊椎導航與機械導引Ecential Robotics

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。