Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Glucommander

K-Number: K152300 · 2017-08-04

ApplicantGlytec, LLC
Decision Date2017-08-04
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Glucommander is a medical device manufactured by Glytec, LLC. It received FDA 510(k) clearance on 2017-08-04 under approval number K152300. 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 Glucommander?

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

When was Glucommander approved by the FDA?

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

What company makes Glucommander?

Glucommander is manufactured by Glytec, LLC.

What is the FDA product code for Glucommander?

The FDA product code for Glucommander is NDC.

Related Devices (Code: NDC)

K160949Go Dose SystemEli Lilly and Company K161433Insulia Diabetes Management CompanionVoluntis Sa. K172177Insulia Diabetes Management CompanionVoluntis Sa. K163664Health-e-Connect System with IDAAlr Technologies K170669Insulia Diabetes Management CompanionVoluntis Sa. K160673Insulin Algorithms SystemInsulin Algorithms

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑