Cleared Traditional

T:SLIM INSULIN DELIVERY SYSTEM

K141758 · Tandem Diabetes Care, Inc. · General Hospital
Oct 2014
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K141758 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. (Philedelphia, US). The FDA issued a Cleared decision on October 31, 2014, 123 days after receiving the submission on June 30, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K141758 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2014
Decision Date October 31, 2014
Days to Decision 123 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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