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FDA 510(k)

iSage Rx (iSage Rx Basal Insulin Titration)

K-Number: K161865 · 2017-03-07

ApplicantIsag Rx, Inc.
Decision Date2017-03-07
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

iSage Rx (iSage Rx Basal Insulin Titration) is a medical device manufactured by Isag Rx, Inc.. It received FDA 510(k) clearance on 2017-03-07 under approval number K161865. 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 iSage Rx (iSage Rx Basal Insulin Titration)?

iSage Rx (iSage Rx Basal Insulin Titration) is a medical device that received FDA 510(k) clearance on 2017-03-07. It is manufactured by Isag Rx, Inc.. The 510(k) number is K161865.

When was iSage Rx (iSage Rx Basal Insulin Titration) approved by the FDA?

iSage Rx (iSage Rx Basal Insulin Titration) received FDA 510(k) clearance on 2017-03-07, under approval number K161865.

What company makes iSage Rx (iSage Rx Basal Insulin Titration)?

iSage Rx (iSage Rx Basal Insulin Titration) is manufactured by Isag Rx, Inc..

What is the FDA product code for iSage Rx (iSage Rx Basal Insulin Titration)?

The FDA product code for iSage Rx (iSage Rx Basal Insulin Titration) is NDC.

Related Clinical Trials

NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT05785832 A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes COMPLETED NCT05944432 CGM Use in Adults With Type 2 Diabetes on Basal Insulin ACTIVE_NOT_RECRUITING NCT06024928 Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes COMPLETED NCT04542148 Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes ACTIVE_NOT_RECRUITING NCT07521475 Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes NOT_YET_RECRUITING

Related Devices (Code: NDC)

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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.

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