Cleared Traditional

DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333

K032164 · Medtronic Minimed · General Hospital
Oct 2003
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K032164 is an FDA 510(k) clearance for the DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on October 23, 2003, 100 days after receiving the submission on July 15, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K032164 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2003
Decision Date October 23, 2003
Days to Decision 100 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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