Cleared Traditional

LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS

K091181 · Smiths Medical MD, Inc. · General Hospital
Jun 2009
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K091181 is an FDA 510(k) clearance for the LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 12, 2009, 50 days after receiving the submission on April 23, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K091181 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2009
Decision Date June 12, 2009
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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