FDA 510(k)

瑞典 & Martina 医療器械監管文本瑞典 & Martina 外科器械架

K 號：K222640 · 2023-05-26

決定日期2023-05-26

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

Sweden & Martina Surgical Trays is the device name listed in this FDA 510(k) record. The listed applicant is Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K222640. 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 Sweden & Martina Surgical Trays?

Sweden & Martina Surgical Trays is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Sweden & Martina S.P.A.. The 510(k) number is K222640.

When did Sweden & Martina Surgical Trays receive FDA 510(k) clearance?

Sweden & Martina Surgical Trays received FDA 510(k) clearance on 2023-05-26, under 510(k) number K222640.

Who is the listed applicant for Sweden & Martina Surgical Trays?

The FDA 510(k) record lists Sweden & Martina S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sweden & Martina Surgical Trays?

The FDA product code for Sweden & Martina Surgical Trays is KCT.

其他以 Sweden & Martina S.P.A. 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。

K182084瑞典 & Martina 外科托盤（型號 ZSHORTY-INT）K180365PRAMA 白色植入系統 K161989預訂級植入系統 SHELTA 植入系統 K172560PREMIUM ONE 假體系統 K162028PREMIUM - SHELTA 假肢零件 K162004預訂級植入系統 SHELTA 植入系統

查看所有 7 項裝置 →

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 K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)Institut Straumann AG K252854SteriTite容器系統搭配MediTray產品Case Medical, Inc.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。