FDA 510(k)

SteriTite容器系統與MediTray產品

K 號：K161415 · 2017-02-10

決定日期2017-02-10

產品代碼FRG

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

SteriTite Containers System & MediTray Products 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 2017-02-10 under 510(k) number K161415. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SteriTite Containers System & MediTray Products?

SteriTite Containers System & MediTray Products is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Case Medical, Inc.. The 510(k) number is K161415.

When did SteriTite Containers System & MediTray Products receive FDA 510(k) clearance?

SteriTite Containers System & MediTray Products received FDA 510(k) clearance on 2017-02-10, under 510(k) number K161415.

Who is the listed applicant for SteriTite Containers System & MediTray Products?

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 SteriTite Containers System & MediTray Products?

The FDA product code for SteriTite Containers System & MediTray Products is FRG.

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 K173259Case醫療用SteriTite可重用硬質消毒容器系統，配備MediTray配件

相關器械（代碼：FRG）

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。

K261897HALYARD* ARMOR-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* HEAVY-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* STANDARD-FLEX* 過濾包裝帶，配備ASSURE-DRY* 技術；HALYARD* H300W 過濾包裝帶，配備ASSURE-DRY* 技術O&M Halyard, Inc.K252823杜卡爾克雷佩紙消毒包覆材Dukal, LLC K253454HALYARD* 一步式* 消毒包材；HALYARD* 快速檢查* 消毒包材；HALYARD* 逐序* 消毒包材；HALYARD* 智能折* 消毒包材O&M Halyard, Inc.K251347消毒袋/卷Sterivic Medical Co., Ltd.K251177自封式消毒袋及卷材Guangdong Maidi Medical Co., Ltd.K250306Chex-All 過濾包及管子Propper Manufacturing Co., 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。