FDA 510(k)

Glooko 行動式胰島素劑量系統

K 號：K171450 · 2018-02-02

決定日期2018-02-02

產品代碼NDC

諮詢委員會AN

決定相當於

器材摘要

Glooko Mobile Insulin Dosing System is the device name listed in this FDA 510(k) record. The listed applicant is Glooko, Inc.. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K171450. 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 Glooko Mobile Insulin Dosing System?

Glooko Mobile Insulin Dosing System is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Glooko, Inc.. The 510(k) number is K171450.

When did Glooko Mobile Insulin Dosing System receive FDA 510(k) clearance?

Glooko Mobile Insulin Dosing System received FDA 510(k) clearance on 2018-02-02, under 510(k) number K171450.

Who is the listed applicant for Glooko Mobile Insulin Dosing System?

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

What is the FDA product code for Glooko Mobile Insulin Dosing System?

The FDA product code for Glooko Mobile Insulin Dosing System is NDC.

其他以 Glooko, Inc. 為申請人之記錄

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K260910EndoTool IV雲端 1.0

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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