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FDA 510(k)

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

K-Number: K162080 · 2016-10-25

ApplicantTandem Diabetes Care, Inc.
Decision Date2016-10-25
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is a medical device manufactured by Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2016-10-25 under approval number K162080. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is a medical device that received FDA 510(k) clearance on 2016-10-25. It is manufactured by Tandem Diabetes Care, Inc.. The 510(k) number is K162080.

When was t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater approved by the FDA?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater received FDA 510(k) clearance on 2016-10-25, under approval number K162080.

What company makes t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is manufactured by Tandem Diabetes Care, Inc..

What is the FDA product code for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

The FDA product code for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is LZG.

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Related PubMed Literature

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Other Devices by Tandem Diabetes Care, Inc.

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 K201214t:slim X2 Insulin Pump with Interoperable Technology

View all 22 devices →

Related Devices (Code: LZG)

K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160252OmniPod Insulin Management SystemInsulet Corporation K162296OmniPod Insulin Management SystemInsulet Corporation K180045Omnipod DASH Insulin Management SystemInsulet Corporation K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation

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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