FDA 510(k)

防篡改蓋子

K 號：K193192 · 2020-01-31

申請人International Medical Industries, Inc.

決定日期2020-01-31

產品代碼FMF

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

Tamper Evident Cap is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Industries, Inc.. It received FDA 510(k) clearance on 2020-01-31 under 510(k) number K193192. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tamper Evident Cap?

Tamper Evident Cap is a medical device that received FDA 510(k) clearance on 2020-01-31. The listed applicant is International Medical Industries, Inc.. The 510(k) number is K193192.

When did Tamper Evident Cap receive FDA 510(k) clearance?

Tamper Evident Cap received FDA 510(k) clearance on 2020-01-31, under 510(k) number K193192.

Who is the listed applicant for Tamper Evident Cap?

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

What is the FDA product code for Tamper Evident Cap?

The FDA product code for Tamper Evident Cap is FMF.

其他以 International Medical Industries, 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。

K231095防篡改蓋子 K201031NRFit® 胶囊，男性及女性神經幹針頭蓋 K190305附加蓋帽 K182545防篡改蓋子配男性Luer Lock K173577守護式Luer連接器 K170672防篡改蓋，適用於ENFit針筒

查看所有 7 項裝置 →

相關器械（代碼：FMF）

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。

K262581GraftGun 適用性移植輸送系統 (GDS®)SurGenTec, LLC K252184SOL-M 輪狀釋放針筒配可交換針盤Sol-Millennium Medical, Inc.K253747一次性針筒注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208超細™ 安全胰島素針embecta Medical II, LLC K253110溶滑安全針；溶滑安全針搭配針筒Sol-Millennium Medical, Inc.K260514Profoject™ 安全針；Profoject™ 配有安全針的注射器；Profoject™ 低死腔配有安全針的注射器CMT Health PTE., Ltd.

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。