FDA 510(k)

K3PRO 外科用盤

K 號：K160574 · 2016-12-20

申請人Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG

決定日期2016-12-20

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

K3PRO SURGICAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. It received FDA 510(k) clearance on 2016-12-20 under 510(k) number K160574. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the K3PRO SURGICAL TRAY?

K3PRO SURGICAL TRAY is a medical device that received FDA 510(k) clearance on 2016-12-20. The listed applicant is Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. The 510(k) number is K160574.

When did K3PRO SURGICAL TRAY receive FDA 510(k) clearance?

K3PRO SURGICAL TRAY received FDA 510(k) clearance on 2016-12-20, under 510(k) number K160574.

Who is the listed applicant for K3PRO SURGICAL TRAY?

The FDA 510(k) record lists Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K3PRO SURGICAL TRAY?

The FDA product code for K3PRO SURGICAL TRAY is KCT.

其他以 Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG 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。

K190192K3Pro Konus 新式基座與植體 K160581K3PRO 頸部附加基座及植入體

相關器械（代碼：KCT）

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。

K253988LiteSet 盤子Nobel Biocare AB K261935外科及義肢托盤Dentsply Sirona, Inc.K253187SteriBest® 過濾消毒托盤系統Mastel Surgical K252854SteriTite容器系統搭配MediTray產品Case Medical, Inc.K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ 快速連接針筒系統托盤；PUREVUE™ 快速連接針筒系統蓋DePuy Mitek, Inc.

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。