Cleared Special

T:SLIM INSULIN DELIVERY SYSTEM

K133593 · Tandem Diabetes Care, Inc. · General Hospital
Mar 2014
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K133593 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 March 24, 2014, 122 days after receiving the submission on November 22, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K133593 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2013
Decision Date March 24, 2014
Days to Decision 122 days
Submission Type Special
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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