Cleared Traditional

CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR

K072144 · Smiths Medical MD, Inc. · General Hospital
Mar 2008
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K072144 is an FDA 510(k) clearance for the CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR, a Pump, Infusion, Pca (Class II — Special Controls, product code MEA), submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 7, 2008, 218 days after receiving the submission on August 2, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K072144 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2007
Decision Date March 07, 2008
Days to Decision 218 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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