FDA 510(k)

Case醫療用SteriTite可重用硬質消毒容器系統，配備MediTray配件

K 號：K173259 · 2018-06-13

決定日期2018-06-13

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

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K173259. 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 Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories?

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Case Medical, Inc.. The 510(k) number is K173259.

When did Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories receive FDA 510(k) clearance?

Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories received FDA 510(k) clearance on 2018-06-13, under 510(k) number K173259.

Who is the listed applicant for Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories?

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

What is the FDA product code for Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories?

The FDA product code for Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories is KCT.

其他以 Case Medical, 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。

K252854SteriTite容器系統搭配MediTray產品 K221492醫用設備規範文本翻譯： SteriTite容器系統搭配MediTray零件 K212711SteriTite容器系統搭配MediTray產品 K161415SteriTite容器系統與MediTray產品

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

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