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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 the device name listed in this FDA 510(k) record. The listed applicant is Isag Rx, Inc.. It received FDA 510(k) clearance on 2017-03-07 under 510(k) 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. The listed applicant is Isag Rx, Inc.. The 510(k) number is K161865.

When did iSage Rx (iSage Rx Basal Insulin Titration) receive FDA 510(k) clearance?

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

Who is the listed applicant for iSage Rx (iSage Rx Basal Insulin Titration)?

The FDA 510(k) record lists Isag Rx, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06024928Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 DiabetesCOMPLETEDNCT07599982Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With DiabetesRECRUITINGNCT07681375Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 SensorACTIVE_NOT_RECRUITING

Related Devices (Code: NDC)

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

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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