Cleared Traditional

MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C

K043600 · Medtronic Minimed · General Hospital
Mar 2005
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K043600 is an FDA 510(k) clearance for the MEDTRONIC MICROMED 407C 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 March 29, 2005, 90 days after receiving the submission on December 29, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K043600 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2004
Decision Date March 29, 2005
Days to Decision 90 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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