FDA 510(k)

OmniPod 胰島素管理系統

K 號：K162296 · 2017-04-18

決定日期2017-04-18

產品代碼LZG

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

OmniPod Insulin Management System is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2017-04-18 under 510(k) number K162296. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OmniPod Insulin Management System?

OmniPod Insulin Management System is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Insulet Corporation. The 510(k) number is K162296.

When did OmniPod Insulin Management System receive FDA 510(k) clearance?

OmniPod Insulin Management System received FDA 510(k) clearance on 2017-04-18, under 510(k) number K162296.

Who is the listed applicant for OmniPod Insulin Management System?

The FDA 510(k) record lists Insulet Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniPod Insulin Management System?

The FDA product code for OmniPod Insulin Management System is LZG.

其他以 Insulet Corporation 為申請人之記錄

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相關器械（代碼：LZG）

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。

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官方來源

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