FDA 510(k)

Glooko 移动胰岛素剂量系统

K号: K171450 · 2018-02-02

决定日期2018-02-02

产品代码NDC

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决定实质等同

器械摘要

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.

常见问题

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.

列明Glooko, Inc.为申报人的其他记录

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