FDA 510(k)

Glooko Mobile Insulin Dosing System

K-Number: K171450 · 2018-02-02

Decision Date2018-02-02

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Glooko, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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