Cleared Traditional

MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C

K040061 · Medtronic Minimed · General Hospital
Apr 2004
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K040061 is an FDA 510(k) clearance for the MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on April 8, 2004, 86 days after receiving the submission on January 13, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K040061 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2004
Decision Date April 08, 2004
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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