Cleared Traditional

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

K162080 · Tandem Diabetes Care, Inc. · General Hospital
Oct 2016
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K162080 is an FDA 510(k) clearance for the t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on October 25, 2016, 90 days after receiving the submission on July 27, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K162080 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2016
Decision Date October 25, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZG — Pump, Infusion, Insulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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