Cleared Traditional

t:slim Insulin Delivery System

K160056 · Tandem Diabetes Care, Inc. · General Hospital
Jul 2016
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K160056 is an FDA 510(k) clearance for the t:slim Insulin Delivery System, 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 July 25, 2016, 195 days after receiving the submission on January 12, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K160056 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2016
Decision Date July 25, 2016
Days to Decision 195 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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