Cleared Traditional

T:SLIM (TM) INSULIN DELIVERY SYSTEM

K111210 · Tandem Diabetes Care, Inc. · General Hospital
Nov 2011
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K111210 is an FDA 510(k) clearance for the T:SLIM (TM) 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 November 9, 2011, 194 days after receiving the submission on April 29, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K111210 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2011
Decision Date November 09, 2011
Days to Decision 194 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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