Cleared Traditional

MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311

K993012 · Medtronic Minimed · General Hospital
Nov 1999
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K993012 is an FDA 510(k) clearance for the MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on November 15, 1999, 68 days after receiving the submission on September 8, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K993012 FDA.gov
FDA Decision Cleared ST
Date Received September 08, 1999
Decision Date November 15, 1999
Days to Decision 68 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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