FDA 510(k)

諾沃彭回聲

K 號：K162602 · 2016-10-18

決定日期2016-10-18

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

NovoPen Echo is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162602. 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 NovoPen Echo?

NovoPen Echo is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Novo Nordisk, Inc.. The 510(k) number is K162602.

When did NovoPen Echo receive FDA 510(k) clearance?

NovoPen Echo received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162602.

Who is the listed applicant for NovoPen Echo?

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

What is the FDA product code for NovoPen Echo?

The FDA product code for NovoPen Echo is FMF.

其他以 Novo Nordisk, 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。

K231255NovoFine® Plus K210258諾沃芬 K202005NovoFine Plus 32G 鋒端 x 4 mm K182387NovoPen Echo 選擇劑量胰島素輸送裝置（針筒注射器）K173479NovoFine 32G針尖（0.23/0.25）x 6 mm ETW（超薄壁）

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

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