FDA 510(k)

Basal-IQ Technology

K-Number: K193483 · 2020-02-28

Decision Date2020-02-28

Product CodeQJS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Basal-IQ Technology is a medical device manufactured by Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2020-02-28 under approval number K193483. The device is classified under product code QJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Basal-IQ Technology?

Basal-IQ Technology is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Tandem Diabetes Care, Inc.. The 510(k) number is K193483.

When was Basal-IQ Technology approved by the FDA?

Basal-IQ Technology received FDA 510(k) clearance on 2020-02-28, under approval number K193483.

What company makes Basal-IQ Technology?

Basal-IQ Technology is manufactured by Tandem Diabetes Care, Inc..

What is the FDA product code for Basal-IQ Technology?

The FDA product code for Basal-IQ Technology is QJS.

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Other Devices by Tandem Diabetes Care, Inc.

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater K160056t:slim Insulin Delivery System K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater DEN190034Control-IQ Technology DEN180058t:slim X2 insulin pump with interoperable technology K200467Control-IQ Technology

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Official Source

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