Cleared Traditional

MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)

K111386 · Smiths Medical MD, Inc. · General Hospital
Aug 2011
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K111386 is an FDA 510(k) clearance for the MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS), a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 29, 2011, 103 days after receiving the submission on May 18, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K111386 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2011
Decision Date August 29, 2011
Days to Decision 103 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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