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)

Insulin Algorithms System

K-Number: K160673 · 2017-06-07

ApplicantInsulin Algorithms
Decision Date2017-06-07
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Insulin Algorithms System is a medical device manufactured by Insulin Algorithms. It received FDA 510(k) clearance on 2017-06-07 under approval number K160673. 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 Insulin Algorithms System?

Insulin Algorithms System is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Insulin Algorithms. The 510(k) number is K160673.

When was Insulin Algorithms System approved by the FDA?

Insulin Algorithms System received FDA 510(k) clearance on 2017-06-07, under approval number K160673.

What company makes Insulin Algorithms System?

Insulin Algorithms System is manufactured by Insulin Algorithms.

What is the FDA product code for Insulin Algorithms System?

The FDA product code for Insulin Algorithms System is NDC.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

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 K152300GlucommanderGlytec, LLC K170669Insulia Diabetes Management CompanionVoluntis Sa.

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.

↑