FDA 510(k)

Glucommander

K 號：K152300 · 2017-08-04

決定日期2017-08-04

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

Glucommander is the device name listed in this FDA 510(k) record. The listed applicant is Glytec, LLC. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K152300. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Glucommander?

Glucommander is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Glytec, LLC. The 510(k) number is K152300.

When did Glucommander receive FDA 510(k) clearance?

Glucommander received FDA 510(k) clearance on 2017-08-04, under 510(k) number K152300.

Who is the listed applicant for Glucommander?

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

What is the FDA product code for Glucommander?

The FDA product code for Glucommander is NDC.

其他以 Glytec, LLC 為申請人之記錄

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K254102Glucommander

相關器械（代碼：NDC）

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。

K254102GlucommanderGlytec, LLC K260910EndoTool IV雲端 1.0Glooko, Inc.K253512迷你美迪 Go AppMedtronic Minimed K253281上醫材Updoc, Inc.K252104T1D1Comerge AG K241088EndoTool IV (3.1)Monarch Medical Technologies

官方來源

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