iSage Rx (iSage Rx Basal Insulin Titration)— 510(k) K161865

Substantially Equivalent

Isag Rx, Inc.

FDA 510(k) clearance K161865 for iSage Rx (iSage Rx Basal Insulin Titration), Substantially Equivalent on 2017-03-07. Applicant: Isag Rx, Inc..

Clearance details

Applicant: Isag Rx, Inc.
Product code: Code NDC
Advisory panel: Anesthesiology
Date received: 2016-07-07
Decision date: 2017-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.